CompletedPhase 1 / PHASE2Results posted

Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease

A Seamless Phase 1b/2a Double-blind, Randomized, Multiple Dose, Multi-center, Sequential Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of TB006 in Patients With Mild to Severe Alzheimer's Disease

Lead sponsor

TrueBinding, Inc.

Asset

TB006

Listed sites

Recruiting sites

Enrollment

154

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 24

Primary endpoints

•Part 1•Clinical Dementia Rating-Sum of Boxes (CDR-SB)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05074498

Org study IDTB006AD2102

Timeline

Milestones

Study start2021-10-08actual

Study first posted2021-10-12actual

Primary completion2022-10-13actual

Study completion2022-10-13actual

Last update posted2023-11-18actual

Results first posted2023-11-18actual

Assets

Drug assets

TB006

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Body weight of ≥ 50 kilograms (kg) and body mass index (BMI) between 18 and 35 kg/meters squared (m^2), inclusive

•Mini-Mental State Examination (MMSE) score of 24 or less

•Must be ambulatory

•Clinical diagnosis of Alzheimer's Disease (AD) consistent with the following:

1. Probable AD, according to National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)

2. Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) - Criteria for Major Neurocognitive Disorder (previously dementia)

•Participants or caregiver has the ability to understand the purpose and risks of the study and provide signed and dated informed consent which includes compliance with the requirements and restrictions listed in the inform consent form (ICF) and in this protocol. Participants whose caregiver signs the informed consent must provide their assent

Exclusion criteria

•Any medical or neurological condition other than AD that in the opinion of the investigator could be a contributing cause of the participant's dementia (e.g., medication use, vitamin B12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, diffuse Lewy body disease, head trauma)

•History within the past 6 months or evidence of clinically significant psychiatric illness (e.g., major depression, schizophrenia, or bipolar affective disorder)

•Diagnosis of a dementia-related central nervous system (CNS) disease other than AD (e.g., Parkinson's Disease, Huntington's Disease, frontotemporal dementia, multi-infarct dementia, dementia with Lewy bodies, normal pressure hydrocephalus)

•Identification of other known cause of dementia or any other clinically significant contributing co-morbid pathologies at screening magnetic resonance imaging (MRI), in the opinion of the investigator

•Participation in any other drug, biologic, device, or clinical study or treatment with any investigational drug or approved therapy for investigational use within 30 days (or 5 half lives, whichever is longer) prior to screening, and/or participation in any other clinical study involving experimental medications for AD within the 60 days (or 5 half lives, whichever is longer) prior to screening

Endpoints (132)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

Global cognition

Behavior / neuropsychiatric

Executive function / language

Global cognition

8 endpoints

Primary/protocol endpoint

Part 2: Change From Baseline Through Day 104 on the Clinical Dementia Rating Scale - Sum of Boxes Total Score

Time frame:Baseline through Day 104

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Primary/registry result

Part 2: Change From Baseline Through Day 104 on the Clinical Dementia Rating Scale - Sum of Boxes Total Score

Time frame:Baseline through Day 104

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Scores on a scale	Standard error
Part 2: TB006 1000 mg qwn=67 Participants	0.01	0.147
Part 2: Placebon=72 Participants	0.35	0.142

Least square mean difference-0.3595% CI-0.741 - 0.047p0.0838Mixed Models Analysis

Secondary/protocol endpoint

Part 2: Change From Baseline Through Day 36 on the Clinical Dementia Rating Scale - Sum of Boxes Total Score

Time frame:Baseline through Day 36

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Part 2: Percentage of Responders on the Clinical Dementia Rating Scale - Sum of Boxes

Time frame:At Days 36 and 104

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

threshold achievement, improvement

Secondary/protocol endpoint

Part 2: Change From Baseline on Mini-Mental State Examination (MMSE) Score

Time frame:Baseline and at Days 36 and 104

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Part 2: Change From Baseline Through Day 36 on the Clinical Dementia Rating Scale - Sum of Boxes Total Score

Time frame:Baseline through Day 36

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Scores on a scale	Standard error
Part 2: TB006 1000 mg qwn=67 Participants	-0.16	0.162
Part 2: Placebon=72 Participants	0.23	0.157

Secondary/registry result

Part 2: Percentage of Responders on the Clinical Dementia Rating Scale - Sum of Boxes

Time frame:At Days 36 and 104

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of responders	Reported bounds
Part 2: TB006 1000 mg qwDay 36n=67 Participants	25.4	-
Day 104n=67 Participants	22.4	-
Part 2: PlaceboDay 36n=72 Participants	9.7	-
Day 104n=72 Participants	15.3	-

Secondary/registry result

Part 2: Change From Baseline on Mini-Mental State Examination (MMSE) Score

Time frame:Baseline and at Days 36 and 104

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Part 2: TB006 1000 mg qwDay 36n=66 Participants	1.2	2.59
Day 104n=63 Participants	1.0	3.10
Part 2: PlaceboDay 36n=70 Participants	0.2	2.52
Day 104n=69 Participants	0.6	2.97

Executive function / language

4 endpoints

Primary/protocol endpoint

Part 1: Number of Participants With Clinically Significant Neurological Examination Findings

Time frame:Up to Day 104

event count, event

Primary/registry result

Part 1: Number of Participants With Clinically Significant Neurological Examination Findings

Time frame:Up to Day 104

event count, event

Secondary/protocol endpoint

Part 2: Number of Participants With Clinically Significant Neurological Examination Findings

Time frame:Up to Day 104

event count, event

Secondary/registry result

Part 2: Number of Participants With Clinically Significant Neurological Examination Findings

Time frame:Up to Day 104

event count, event

Behavior / neuropsychiatric

6 endpoints

Primary/protocol endpoint

Part 1: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)

Time frame:Up to Day 104

event count, event

Primary/registry result

Part 1: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)

Time frame:Up to Day 104

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Part 1: TB006 140 Milligrams (mg) Weekly (qw)Wish to be deadn=7 Participants	0	-
Non-specific active suicidal thoughtsn=7 Participants	0	-
Active suicidal ideation without any methods without intent to actn=7 Participants	0	-
Active suicidal ideation with some intent to act, without specific plann=7 Participants	0	-
Active suicidal ideation with specific plan and intentn=7 Participants	0	-
Any suicidal behaviorn=7 Participants	0	-
Actual attemptn=7 Participants	0	-
Interrupted attemptn=7 Participants	0	-
Aborted attemptn=7 Participants	0	-
Preparatory acts or behaviorn=7 Participants	0	-
Most recent attemptn=7 Participants	0	-
First attemptn=7 Participants	0	-
Lethal attemptn=7 Participants	0	-
Part 1: TB006 420 mg qwWish to be deadn=6 Participants	0	-
Non-specific active suicidal thoughtsn=6 Participants	0	-
Active suicidal ideation without any methods without intent to actn=6 Participants	0	-
Active suicidal ideation with some intent to act, without specific plann=6 Participants	0	-
Active suicidal ideation with specific plan and intentn=6 Participants	0	-
Any suicidal behaviorn=6 Participants	0	-
Actual attemptn=6 Participants	0	-
Interrupted attemptn=6 Participants	0	-
Aborted attemptn=6 Participants	0	-
Preparatory acts or behaviorn=6 Participants	0	-
Most recent attemptn=6 Participants	0	-
First attemptn=6 Participants	0	-
Lethal attemptn=6 Participants	0	-
Part 1: TB006 1000 mg qwWish to be deadn=6 Participants	0	-
Non-specific active suicidal thoughtsn=6 Participants	0	-
Active suicidal ideation without any methods without intent to actn=6 Participants	0	-
Active suicidal ideation with some intent to act, without specific plann=6 Participants	0	-
Active suicidal ideation with specific plan and intentn=6 Participants	0	-
Any suicidal behaviorn=6 Participants	0	-
Actual attemptn=6 Participants	0	-
Interrupted attemptn=6 Participants	0	-
Aborted attemptn=6 Participants	0	-
Preparatory acts or behaviorn=6 Participants	0	-
Most recent attemptn=6 Participants	0	-
First attemptn=6 Participants	0	-
Lethal attemptn=6 Participants	0	-
Part 1: PlaceboWish to be deadn=5 Participants	0	-
Non-specific active suicidal thoughtsn=5 Participants	0	-
Active suicidal ideation without any methods without intent to actn=5 Participants	0	-
Active suicidal ideation with some intent to act, without specific plann=5 Participants	0	-
Active suicidal ideation with specific plan and intentn=5 Participants	0	-
Any suicidal behaviorn=5 Participants	0	-
Actual attemptn=5 Participants	0	-
Interrupted attemptn=5 Participants	0	-
Aborted attemptn=5 Participants	0	-
Preparatory acts or behaviorn=5 Participants	0	-
Most recent attemptn=5 Participants	0	-
First attemptn=5 Participants	0	-
Lethal attemptn=5 Participants	0	-

Secondary/protocol endpoint

Part 2: Change From Baseline on the Neuropsychiatric Inventory (NPI) Score

Time frame:Baseline and at Days 36 and 104

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Part 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS

Time frame:Up to Day 104

event count, event

Secondary/registry result

Part 2: Change From Baseline on the Neuropsychiatric Inventory (NPI) Score

Time frame:Baseline and at Days 36 and 104

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Part 2: TB006 1000 mg qwDay 36n=66 Participants	-2.5	8.10
Day 104n=63 Participants	-3.5	11.47
Part 2: PlaceboDay 36n=69 Participants	-0.8	9.12
Day 104n=69 Participants	-1.1	6.79

Secondary/registry result

Part 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS

Time frame:Up to Day 104

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Part 2: TB006 1000 mg qwWish to be deadn=58 Participants	0	-
Non-specific active suicidal thoughtsn=58 Participants	0	-
Active suicidal ideation without any methods without intent to actn=58 Participants	0	-
Active suicidal ideation with some intent to act, without specific plann=58 Participants	0	-
Active suicidal ideation with specific plan and intentn=58 Participants	0	-
Any suicidal behaviorn=58 Participants	0	-
Actual attemptn=58 Participants	0	-
Interrupted attemptn=58 Participants	0	-
Aborted attemptn=58 Participants	0	-
Preparatory acts or behaviorn=58 Participants	0	-
Most recent attemptn=58 Participants	0	-
First attemptn=58 Participants	0	-
Lethal attemptn=58 Participants	0	-
Part 2: PlaceboWish to be deadn=64 Participants	0	-
Non-specific active suicidal thoughtsn=64 Participants	0	-
Active suicidal ideation without any methods without intent to actn=64 Participants	0	-
Active suicidal ideation with some intent to act, without specific plann=64 Participants	0	-
Active suicidal ideation with specific plan and intentn=64 Participants	0	-
Any suicidal behaviorn=64 Participants	0	-
Actual attemptn=64 Participants	0	-
Interrupted attemptn=64 Participants	0	-
Aborted attemptn=64 Participants	0	-
Preparatory acts or behaviorn=64 Participants	0	-
Most recent attemptn=64 Participants	0	-
First attemptn=64 Participants	0	-
Lethal attemptn=64 Participants	0	-

Safety / tolerability / PK

38 endpoints

Primary/protocol endpoint

Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:Up to Day 104

event count, event

Primary/protocol endpoint

Part 1: Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

Time frame:Baseline and Up to Day 104

change from baseline, event

Primary/protocol endpoint

Part 1: Change From Baseline in Respiratory Rate

Time frame:Baseline and Up to Day 104

change from baseline, event

Primary/protocol endpoint

Part 1: Change From Baseline in Temperature

Time frame:Baseline and Up to Day 104

change from baseline, event

Primary/protocol endpoint

Part 1: Change From Baseline in Heart Rate

Time frame:Baseline and Up to Day 104

change from baseline, event

Primary/registry result

Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:Up to Day 104

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Part 1: TB006 140 Milligrams (mg) Weekly (qw)Any AEn=7 Participants	5	-
Any SAEn=7 Participants	1	-
Part 1: TB006 420 mg qwAny AEn=6 Participants	4	-
Any SAEn=6 Participants	0	-
Part 1: TB006 1000 mg qwAny AEn=6 Participants	1	-
Any SAEn=6 Participants	0	-
Part 1: PlaceboAny AEn=6 Participants	2	-
Any SAEn=6 Participants	0	-

Primary/protocol endpoint

Part 1: Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate

Time frame:Baseline and Up to Day 104

change from baseline, event

Primary/protocol endpoint

Part 1: Number of Participants With Clinically Significant Physical Examination Findings

Time frame:Up to Day 104

event count, event

Primary/protocol endpoint

Part 1: Dose Normalized Area Under the Concentration Time Curve Over a Dosing Interval (AUCtau) of TB006

Time frame:Day 1 and Day 29

concentration, descriptive

Primary/protocol endpoint

Part 1: Time at Which Maximum Plasma Concentration Occurs (Tmax) of TB006

Time frame:At Days 1, 8 and 29

concentration, descriptive

Primary/protocol endpoint

Part 1: Dose Normalized Maximum Observed Plasma Concentration (Cmax) of TB006

Time frame:At Days 1, 8 and 29

concentration, descriptive

Primary/protocol endpoint

Part 1: Terminal Elimination Phase Half-life (t1/2) of TB006

Time frame:At Day 29

concentration, descriptive

Primary/protocol endpoint

Part 1: Number of Participants With Anti-TB006 Antibodies (Immunogenicity of TB006)

Time frame:Day 1 (Predose), Day 8 (Predose), Day 36 and Day 104

event count, event

Primary/registry result

Part 1: Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

Time frame:Baseline and Up to Day 104

change from baseline, event

Posted result

Group	Value (mean), Millimeters of mercury	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)DBPn=7 Participants	-2.1	12.06
SBPn=7 Participants	-10.4	13.39
Part 1: TB006 420 mg qwDBPn=6 Participants	-2.3	10.37
SBPn=6 Participants	3.5	9.61
Part 1: TB006 1000 mg qwDBPn=6 Participants	-1.0	3.03
SBPn=6 Participants	-6.2	13.17
Part 1: PlaceboDBPn=5 Participants	-7.2	9.09
SBPn=5 Participants	2.2	17.74

Primary/registry result

Part 1: Change From Baseline in Respiratory Rate

Time frame:Baseline and Up to Day 104

change from baseline, event

Posted result

Group	Value (mean), breaths per minute	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)n=7 Participants	0.0	0.00
Part 1: TB006 420 mg qwn=6 Participants	-0.7	2.16
Part 1: TB006 1000 mg qwn=6 Participants	0.3	1.03
Part 1: Placebon=5 Participants	-0.2	1.30

Primary/registry result

Part 1: Change From Baseline in Temperature

Time frame:Baseline and Up to Day 104

change from baseline, event

Posted result

Group	Value (mean), degrees Celsius	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)n=7 Participants	0.26	0.351
Part 1: TB006 420 mg qwn=6 Participants	-0.37	0.350
Part 1: TB006 1000 mg qwn=6 Participants	-0.03	0.833
Part 1: Placebon=5 Participants	-0.22	0.130

Primary/registry result

Part 1: Change From Baseline in Heart Rate

Time frame:Baseline and Up to Day 104

change from baseline, event

Posted result

Group	Value (mean), Beats per minute	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)n=7 Participants	-2.0	8.00
Part 1: TB006 420 mg qwn=6 Participants	3.3	3.72
Part 1: TB006 1000 mg qwn=6 Participants	4.0	5.73
Part 1: Placebon=5 Participants	-4.2	9.50

Primary/registry result

Part 1: Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate

Time frame:Baseline and Up to Day 104

change from baseline, event

Posted result

Group	Value (mean), Beats per minute	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)n=7 Participants	-4.8	5.78
Part 1: TB006 420 mg qwn=6 Participants	-0.9	4.00
Part 1: TB006 1000 mg qwn=6 Participants	3.0	3.82
Part 1: Placebon=5 Participants	-3.4	4.87

Primary/registry result

Part 1: Number of Participants With Clinically Significant Physical Examination Findings

Time frame:Up to Day 104

event count, event

Primary/registry result

Part 1: Dose Normalized Area Under the Concentration Time Curve Over a Dosing Interval (AUCtau) of TB006

Time frame:Day 1 and Day 29

concentration, descriptive

Posted result

Group	Value (geometric_mean), hours*micrograms/milliliter/milligram	Geometric coefficient of variation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)Day 1n=6 Participants	39.81	23.17
Day 29n=7 Participants	125.92	18.01
Part 1: TB006 420 mg qwDay 1n=5 Participants	29.87	38.15
Day 29n=6 Participants	117.75	24.52
Part 1: TB006 1000 mg qwDay 1n=2 Participants	11.93	100.21
Day 29n=5 Participants	82.95	18.18

Primary/registry result

Part 1: Time at Which Maximum Plasma Concentration Occurs (Tmax) of TB006

Time frame:At Days 1, 8 and 29

concentration, descriptive

Posted result

Group	Value (median), hours	Reported bounds
Part 1: TB006 140 Milligrams (mg) Weekly (qw)Day 1n=7 Participants	1.12	-1.0 - 7.0
Day 8n=7 Participants	1.23	-1.0 - 2.0
Day 29n=7 Participants	2.03	-1.1 - 5.1
Part 1: TB006 420 mg qwDay 1n=6 Participants	2.01	-1.1 - 5.0
Day 8n=6 Participants	1.60	-1.2 - 5.0
Day 29n=6 Participants	2.18	-1.1 - 7.0
Part 1: TB006 1000 mg qwDay 1n=6 Participants	2.00	-1.0 - 5.0
Day 8n=6 Participants	2.50	-1.1 - 5.0
Day 29n=5 Participants	2.00	-1.0 - 7.0

Primary/registry result

Part 1: Dose Normalized Maximum Observed Plasma Concentration (Cmax) of TB006

Time frame:At Days 1, 8 and 29

concentration, descriptive

Posted result

Group	Value (geometric_mean), micrograms/milliliter/milligram	Geometric coefficient of variation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)Day 1n=7 Participants	0.36	25.72
Day 8n=7 Participants	0.58	27.57
Day 29n=7 Participants	0.95	18.15
Part 1: TB006 420 mg qwDay 1n=6 Participants	0.29	36.97
Day 8n=6 Participants	0.49	26.77
Day 29n=6 Participants	0.85	22.89
Part 1: TB006 1000 mg qwDay 1n=6 Participants	0.07	105.32
Day 8n=6 Participants	0.30	30.27
Day 29n=5 Participants	0.61	13.40

Primary/registry result

Part 1: Terminal Elimination Phase Half-life (t1/2) of TB006

Time frame:At Day 29

concentration, descriptive

Posted result

Group	Value (geometric_mean), hours	Geometric coefficient of variation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)n=7 Participants	711.49	19.87
Part 1: TB006 420 mg qwn=6 Participants	757.59	22.80
Part 1: TB006 1000 mg qwn=4 Participants	739.50	14.90

Primary/registry result

Part 1: Number of Participants With Anti-TB006 Antibodies (Immunogenicity of TB006)

Time frame:Day 1 (Predose), Day 8 (Predose), Day 36 and Day 104

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Part 1: TB006 140 Milligrams (mg) Weekly (qw)Day 1 (Predose)n=7 Participants	0	-
Day 8 (Predose)n=7 Participants	0	-
Day 36n=7 Participants	0	-
Day 104n=7 Participants	1	-
Part 1: TB006 420 mg qwDay 1 (Predose)n=6 Participants	0	-
Day 8 (Predose)n=6 Participants	0	-
Day 36n=6 Participants	0	-
Day 104n=6 Participants	0	-
Part 1: TB006 1000 mg qwDay 1 (Predose)n=6 Participants	0	-
Day 8 (Predose)n=6 Participants	0	-
Day 36n=6 Participants	0	-
Day 104n=6 Participants	0	-
Part 1: PlaceboDay 1 (Predose)n=6 Participants	0	-
Day 8 (Predose)n=6 Participants	0	-
Day 36n=6 Participants	0	-
Day 104n=6 Participants	0	-

Secondary/protocol endpoint

Part 2: Number of Participants With AEs and SAEs

Time frame:Up to Day 104

event count, event

Secondary/protocol endpoint

Part 2: Change From Baseline in DBP and SBP

Time frame:Baseline and Up to Day 104

change from baseline, event

Secondary/protocol endpoint

Part 2: Change From Baseline in Respiratory Rate

Time frame:Baseline and Up to Day 104

change from baseline, event

Secondary/protocol endpoint

Part 2: Change From Baseline in Temperature

Time frame:Baseline and Up to Day 104

change from baseline, event

Secondary/protocol endpoint

Part 2: Change From Baseline in Heart Rate

Time frame:Baseline and Up to Day 104

change from baseline, event

Secondary/protocol endpoint

Part 2: Number of Participants With Clinically Significant Physical Examination Findings

Time frame:Up to Day 104

event count, event

Secondary/protocol endpoint

Part 2: Cmax of TB006

Time frame:Day 1 and Day 29

concentration, descriptive

Secondary/registry result

Part 2: Number of Participants With AEs and SAEs

Time frame:Up to Day 104

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Part 2: TB006 1000 mg qwAny AEn=63 Participants	28	-
Any SAEn=63 Participants	4	-
Part 2: PlaceboAny AEn=66 Participants	17	-
Any SAEn=66 Participants	1	-

Secondary/registry result

Part 2: Change From Baseline in DBP and SBP

Time frame:Baseline and Up to Day 104

change from baseline, event

Posted result

Group	Value (mean), Millimeters of mercury	Standard deviation
Part 2: TB006 1000 mg qwDBPn=58 Participants	0.8	6.42
SBPn=58 Participants	1.4	15.02
Part 2: PlaceboDBPn=64 Participants	0.7	9.48
SBPn=64 Participants	0.0	15.57

Secondary/registry result

Part 2: Change From Baseline in Respiratory Rate

Time frame:Baseline and Up to Day 104

change from baseline, event

Posted result

Group	Value (mean), breaths per minute	Standard deviation
Part 2: TB006 1000 mg qwn=58 Participants	0.1	0.97
Part 2: Placebon=64 Participants	0.2	0.97

Secondary/registry result

Part 2: Change From Baseline in Temperature

Time frame:Baseline and Up to Day 104

change from baseline, event

Posted result

Group	Value (mean), degrees Celsius	Standard deviation
Part 2: TB006 1000 mg qwn=58 Participants	0.01	0.489
Part 2: Placebon=64 Participants	-0.03	0.461

Secondary/registry result

Part 2: Change From Baseline in Heart Rate

Time frame:Baseline and Up to Day 104

change from baseline, event

Posted result

Group	Value (mean), Beats per minute	Standard deviation
Part 2: TB006 1000 mg qwn=58 Participants	-4.2	8.59
Part 2: Placebon=64 Participants	-2.1	7.86

Secondary/registry result

Part 2: Number of Participants With Clinically Significant Physical Examination Findings

Time frame:Up to Day 104

event count, event

Secondary/registry result

Part 2: Cmax of TB006

Time frame:Day 1 and Day 29

concentration, descriptive

Posted result

Group	Value (geometric_mean), Micrograms per milliliter	Geometric coefficient of variation
Part 2: TB006 1000 mg qwDay 1n=58 Participants	339.17	23.82
Day 29n=56 Participants	731.55	25.13

Other (unclassified)

76 endpoints

Primary/protocol endpoint/low confidence

Part 1: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Kinase (CK)

Time frame:Baseline and up to Day 104

change from baseline, improvement

Primary/protocol endpoint/low confidence

Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein

Time frame:Baseline and up to Day 104

change from baseline, improvement

Primary/protocol endpoint/low confidence

Part 1: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL (High Density Lipoprotein) Cholesterol, LDL (Low Density Lipoprotein) Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen

Time frame:Baseline and up to Day 104

change from baseline, improvement

Primary/protocol endpoint/low confidence

Part 1: Change From Baseline in Clinical Chemistry Parameter: Hemoglobin A1C

Time frame:Baseline and up to Day 104

change from baseline, improvement

Primary/protocol endpoint/low confidence

Part 1: Change From Baseline in Clinical Chemistry Parameters: Potassium and Sodium

Time frame:Baseline and up to Day 104

change from baseline, improvement

Primary/protocol endpoint/low confidence

Part 1: Change From Baseline in Clinical Chemistry Parameter: Thyrotropin

Time frame:Baseline and up to Day 104

change from baseline, improvement

Primary/protocol endpoint/low confidence

Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets

Time frame:Baseline and up to Day 104

change from baseline, improvement

Primary/protocol endpoint/low confidence

Part 1: Change From Baseline in Hematology Parameter: Erythrocyte. Mean Corpuscular Hemoglobin (Ery. MCH)

Time frame:Baseline and up to Day 104

change from baseline, improvement

Primary/protocol endpoint/low confidence

Part 1: Change From Baseline in Hematology Parameter: Hematocrit

Time frame:Baseline and up to Day 104

change from baseline, improvement

Primary/protocol endpoint/low confidence

Part 1: Change From Baseline in Hematology Parameter: Erythrocytes and Reticulocytes

Time frame:Baseline and up to Day 104

change from baseline, improvement

Primary/protocol endpoint/low confidence

Part 1: Change From Baseline in Hematology Parameter: Erythrocyte. Mean Corpuscular Volume (Ery. MCV)

Time frame:Baseline and up to Day 104

change from baseline, improvement

Primary/protocol endpoint/low confidence

Part 1: Change From Baseline in Hematology Parameter: Hemoglobin

Time frame:Baseline and up to Day 104

change from baseline, improvement

Primary/protocol endpoint/low confidence

Part 1: Change From Baseline in Urine Potential of Hydrogen (pH)

Time frame:Baseline and up to Day 104

change from baseline, improvement

Primary/protocol endpoint/low confidence

Part 1: Change From Baseline in Urine Specific Gravity

Time frame:Baseline and up to Day 104

change from baseline, improvement

Primary/protocol endpoint/low confidence

Part 1: Change From Baseline in Urobilinogen

Time frame:Baseline and up to Day 104

change from baseline, improvement

Primary/registry result/low confidence

Part 1: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Kinase (CK)

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), International Units per Liter	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)ALTn=7 Participants	-1.7	2.21
ALPn=7 Participants	-0.6	9.11
ASTn=7 Participants	-0.1	2.27
CKn=7 Participants	22.0	39.27
Part 1: TB006 420 mg qwALTn=6 Participants	-5.5	5.32
ALPn=6 Participants	-4.0	5.59
ASTn=6 Participants	-3.8	5.23
CKn=6 Participants	0.5	44.37
Part 1: TB006 1000 mg qwALTn=6 Participants	-0.7	10.33
ALPn=6 Participants	-2.2	10.05
ASTn=6 Participants	-1.3	7.61
CKn=6 Participants	0.3	65.56
Part 1: PlaceboALTn=5 Participants	5.4	14.79
ALPn=5 Participants	9.0	15.98
ASTn=5 Participants	3.2	13.65
CKn=5 Participants	-10.4	14.03

Primary/protocol endpoint/low confidence

Part 1: Change From Baseline in ECG Parameters

Time frame:Baseline and Up to Day 104

change from baseline, improvement

Primary/registry result/low confidence

Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), grams per deciliter	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)Albuminn=7 Participants	-0.14	0.199
Proteinn=7 Participants	-0.20	0.316
Part 1: TB006 420 mg qwAlbuminn=6 Participants	0.02	0.098
Proteinn=6 Participants	0.12	0.183
Part 1: TB006 1000 mg qwAlbuminn=6 Participants	-0.03	0.367
Proteinn=6 Participants	-0.05	0.589
Part 1: PlaceboAlbuminn=5 Participants	-0.04	0.167
Proteinn=5 Participants	-0.08	0.363

Primary/registry result/low confidence

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), milligrams per deciliter	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)Calciumn=7 Participants	-0.13	0.373
Cholesteroln=7 Participants	-15.4	21.62
Creatininen=7 Participants	0.047	0.081
Direct Bilirubinn=7 Participants	-0.007	0.032
Glucosen=7 Participants	34.3	55.23
HDL Cholesteroln=7 Participants	-3.6	5.19
LDL Cholesteroln=7 Participants	-9.0	9.04
Total Bilirubinn=7 Participants	-0.036	0.093
Triglyceridesn=7 Participants	-23.3	69.65
Urea Nitrogenn=7 Participants	-0.40	2.171
Part 1: TB006 420 mg qwCalciumn=6 Participants	0.17	0.280
Cholesteroln=6 Participants	-2.7	10.35
Creatininen=6 Participants	0.153	0.377
Direct Bilirubinn=6 Participants	-0.003	0.033
Glucosen=6 Participants	-15.0	18.51
HDL Cholesteroln=6 Participants	-3.0	4.65
LDL Cholesteroln=6 Participants	-1.8	9.33
Total Bilirubinn=6 Participants	-0.005	0.227
Triglyceridesn=6 Participants	12.2	17.72
Urea Nitrogenn=6 Participants	6.95	8.277
Part 1: TB006 1000 mg qwCalciumn=6 Participants	-0.02	0.360
Cholesteroln=6 Participants	6.2	74.37
Creatininen=6 Participants	0.108	0.143
Direct Bilirubinn=6 Participants	0.000	0.020
Glucosen=6 Participants	21.3	45.45
HDL Cholesteroln=6 Participants	0.2	13.98
LDL Cholesteroln=6 Participants	-3.5	64.62
Total Bilirubinn=6 Participants	0.032	0.132
Triglyceridesn=6 Participants	18.7	104.95
Urea Nitrogenn=6 Participants	2.43	3.449
Part 1: PlaceboCalciumn=5 Participants	-0.18	0.356
Cholesteroln=5 Participants	-13.4	47.79
Creatininen=5 Participants	-0.040	0.142
Direct Bilirubinn=5 Participants	-0.022	0.030
Glucosen=5 Participants	8.2	49.94
HDL Cholesteroln=5 Participants	4.0	17.13
LDL Cholesteroln=5 Participants	-14.8	46.23
Total Bilirubinn=5 Participants	-0.134	0.225
Triglyceridesn=5 Participants	-23.8	39.06
Urea Nitrogenn=5 Participants	1.30	4.266

Primary/registry result/low confidence

Part 1: Change From Baseline in Clinical Chemistry Parameter: Hemoglobin A1C

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), percentage of glycosylated hemoglobin	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)n=7 Participants	0.06	0.162
Part 1: TB006 420 mg qwn=6 Participants	-0.02	0.567
Part 1: TB006 1000 mg qwn=6 Participants	-0.33	0.625
Part 1: Placebon=5 Participants	-0.14	1.011

Primary/registry result/low confidence

Part 1: Change From Baseline in Clinical Chemistry Parameters: Potassium and Sodium

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), Millimoles per liter	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)Potassiumn=7 Participants	0.10	0.476
Sodiumn=7 Participants	-1.0	2.24
Part 1: TB006 420 mg qwPotassiumn=6 Participants	-0.15	0.288
Sodiumn=6 Participants	0.8	1.72
Part 1: TB006 1000 mg qwPotassiumn=6 Participants	0.07	0.378
Sodiumn=6 Participants	-1.2	2.56
Part 1: PlaceboPotassiumn=5 Participants	0.02	0.259
Sodiumn=5 Participants	-1.2	2.39

Primary/registry result/low confidence

Part 1: Change From Baseline in Clinical Chemistry Parameter: Thyrotropin

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), micro-international units per milliliter	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)n=7 Participants	1.209	3.114
Part 1: TB006 420 mg qwn=6 Participants	-0.343	0.298
Part 1: TB006 1000 mg qwn=6 Participants	-0.370	1.312
Part 1: Placebon=5 Participants	-0.246	0.372

Primary/registry result/low confidence

Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), 10^3 cells per microliter	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)Basophilsn=7 Participants	-0.023	0.015
Eosinophilsn=7 Participants	0.014	0.138
Leukocytesn=7 Participants	-0.76	0.650
Lymphocytesn=7 Participants	-0.264	0.188
Monocytesn=7 Participants	-0.094	0.118
Neutrophilsn=7 Participants	-0.396	0.719
Plateletsn=7 Participants	-9.1	37.53
Part 1: TB006 420 mg qwBasophilsn=6 Participants	-0.005	0.019
Eosinophilsn=6 Participants	0.003	0.068
Leukocytesn=6 Participants	0.00	1.292
Lymphocytesn=6 Participants	-0.025	0.241
Monocytesn=6 Participants	-0.017	0.114
Neutrophilsn=6 Participants	0.078	1.171
Plateletsn=6 Participants	5.0	37.25
Part 1: TB006 1000 mg qwBasophilsn=6 Participants	0.005	0.028
Eosinophilsn=6 Participants	0.038	0.089
Leukocytesn=6 Participants	0.40	1.563
Lymphocytesn=6 Participants	-0.037	1.265
Monocytesn=6 Participants	0.032	0.108
Neutrophilsn=6 Participants	0.368	0.641
Plateletsn=5 Participants	-9.6	89.83
Part 1: PlaceboBasophilsn=5 Participants	0.006	0.013
Eosinophilsn=5 Participants	0.030	0.173
Leukocytesn=5 Participants	-0.28	1.092
Lymphocytesn=5 Participants	-0.036	0.250
Monocytesn=5 Participants	0.028	0.062
Neutrophilsn=5 Participants	-0.318	1.145
Plateletsn=4 Participants	-4.5	50.16

Primary/registry result/low confidence

Part 1: Change From Baseline in Hematology Parameter: Erythrocyte. Mean Corpuscular Hemoglobin (Ery. MCH)

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), picograms	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)n=7 Participants	-0.40	1.134
Part 1: TB006 420 mg qwn=6 Participants	-0.05	0.579
Part 1: TB006 1000 mg qwn=6 Participants	1.02	3.511
Part 1: Placebon=5 Participants	-0.34	0.631

Primary/protocol endpoint/low confidence

Part 1: Concentration at the End of a Dosing Interval (Ctrough) of TB006

Time frame:Day 8 and Day 29

concentration, descriptive

Primary/registry result/low confidence

Part 1: Change From Baseline in Hematology Parameter: Hematocrit

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), Percentage	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)n=7 Participants	0.69	2.563
Part 1: TB006 420 mg qwn=6 Participants	1.18	2.105
Part 1: TB006 1000 mg qwn=6 Participants	1.18	7.919
Part 1: Placebon=5 Participants	0.32	2.493

Primary/registry result/low confidence

Part 1: Change From Baseline in Hematology Parameter: Erythrocytes and Reticulocytes

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), 10^6 cells per microliter	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)Erythrocytesn=7 Participants	0.039	0.401
Reticulocytesn=7 Participants	-0.011	0.017
Part 1: TB006 420 mg qwErythrocytesn=6 Participants	0.012	0.219
Reticulocytesn=6 Participants	-0.005	0.004
Part 1: TB006 1000 mg qwErythrocytesn=6 Participants	-0.108	0.625
Reticulocytesn=6 Participants	-0.008	0.008
Part 1: PlaceboErythrocytesn=5 Participants	0.024	0.211
Reticulocytesn=5 Participants	-0.005	0.009

Primary/protocol endpoint/low confidence

Part 1: Total Clearance (CL) of TB006

Time frame:At Day 29

descriptive

Primary/registry result/low confidence

Part 1: Change From Baseline in Hematology Parameter: Erythrocyte. Mean Corpuscular Volume (Ery. MCV)

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), femtoliters	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)n=7 Participants	0.80	1.926
Part 1: TB006 420 mg qwn=6 Participants	2.45	1.343
Part 1: TB006 1000 mg qwn=6 Participants	5.42	5.724
Part 1: Placebon=5 Participants	0.20	2.699

Primary/protocol endpoint/low confidence

Part 1: Volume of Distribution (Vd) of TB006

Time frame:At Day 29

descriptive

Primary/registry result/low confidence

Part 1: Change From Baseline in Hematology Parameter: Hemoglobin

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), grams per deciliter	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)n=7 Participants	-0.06	0.779
Part 1: TB006 420 mg qwn=6 Participants	0.00	0.465
Part 1: TB006 1000 mg qwn=6 Participants	0.08	3.260
Part 1: Placebon=5 Participants	-0.10	0.877

Primary/registry result/low confidence

Part 1: Change From Baseline in Urine Potential of Hydrogen (pH)

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), potential of Hydrogen	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)n=7 Participants	-0.36	1.215
Part 1: TB006 420 mg qwn=5 Participants	0.40	1.294
Part 1: TB006 1000 mg qwn=6 Participants	-0.50	1.612
Part 1: Placebon=5 Participants	-0.80	0.975

Primary/registry result/low confidence

Part 1: Change From Baseline in Urine Specific Gravity

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), Ratio	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)n=7 Participants	0.003	0.008
Part 1: TB006 420 mg qwn=5 Participants	0.003	0.006
Part 1: TB006 1000 mg qwn=6 Participants	0.004	0.011
Part 1: Placebon=5 Participants	0.007	0.010

Primary/registry result/low confidence

Part 1: Change From Baseline in Urobilinogen

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), milligrams per deciliter	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)n=7 Participants	0.00	0.462
Part 1: TB006 420 mg qwn=5 Participants	-0.16	0.358
Part 1: TB006 1000 mg qwn=6 Participants	-0.13	0.602
Part 1: Placebon=5 Participants	0.00	0.000

Primary/registry result/low confidence

Part 1: Change From Baseline in ECG Parameters

Time frame:Baseline and Up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), milliseconds	Standard deviation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)PR Intervaln=7 Participants	4.8	10.07
QRS Durationn=7 Participants	0.3	3.07
QT Intervaln=7 Participants	21.9	12.72
QTcB Intervaln=7 Participants	8.1	11.37
Part 1: TB006 420 mg qwPR Intervaln=6 Participants	0.7	5.90
QRS Durationn=6 Participants	1.1	5.27
QT Intervaln=6 Participants	-2.9	10.48
QTcB Intervaln=6 Participants	-6.6	12.98
Part 1: TB006 1000 mg qwPR Intervaln=6 Participants	-11.0	14.74
QRS Durationn=6 Participants	1.0	7.16
QT Intervaln=6 Participants	0.3	9.36
QTcB Intervaln=6 Participants	9.9	11.50
Part 1: PlaceboPR Intervaln=5 Participants	14.9	5.16
QRS Durationn=5 Participants	-4.1	13.50
QT Intervaln=5 Participants	-5.0	11.47
QTcB Intervaln=5 Participants	-15.2	4.15

Primary/registry result/low confidence

Part 1: Concentration at the End of a Dosing Interval (Ctrough) of TB006

Time frame:Day 8 and Day 29

concentration, descriptive

Posted result

Group	Value (geometric_mean), micrograms per milliliter	Geometric coefficient of variation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)Day 8n=7 Participants	25.77	21.23
Day 29n=7 Participants	76.69	19.62
Part 1: TB006 420 mg qwDay 8n=5 Participants	71.44	20.75
Day 29n=6 Participants	204.77	20.46
Part 1: TB006 1000 mg qwDay 8n=3 Participants	68.62	70.91
Day 29n=5 Participants	348.20	22.34

Primary/registry result/low confidence

Part 1: Total Clearance (CL) of TB006

Time frame:At Day 29

descriptive

Posted result

Group	Value (geometric_mean), milliliters per hour	Geometric coefficient of variation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)n=7 Participants	7.94	17.06
Part 1: TB006 420 mg qwn=6 Participants	8.49	19.27
Part 1: TB006 1000 mg qwn=5 Participants	12.06	19.68

Primary/registry result/low confidence

Part 1: Volume of Distribution (Vd) of TB006

Time frame:At Day 29

descriptive

Posted result

Group	Value (geometric_mean), milliliters	Geometric coefficient of variation
Part 1: TB006 140 Milligrams (mg) Weekly (qw)n=7 Participants	8151.47	21.38
Part 1: TB006 420 mg qwn=6 Participants	9282.51	28.97
Part 1: TB006 1000 mg qwn=4 Participants	13617.70	30.63

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK

Time frame:Baseline and up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein

Time frame:Baseline and up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL Cholesterol, LDL Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen

Time frame:Baseline and up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in Clinical Chemistry Parameter: Hemoglobin A1C

Time frame:Baseline and up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in Clinical Chemistry Parameters: Potassium and Sodium

Time frame:Baseline and up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in Clinical Chemistry Parameter: Thyrotropin

Time frame:Baseline and up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets

Time frame:Baseline and up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in Hematology Parameter: Ery. MCH

Time frame:Baseline and up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in Hematology Parameter: Ery. MCV

Time frame:Baseline and up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in Hematology Parameter: Erythrocytes and Reticulocytes

Time frame:Baseline and up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in Hematology Parameter: Hematocrit

Time frame:Baseline and up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in Hematology Parameter: Hemoglobin

Time frame:Baseline and up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in Urine pH

Time frame:Baseline and up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in Urine Specific Gravity

Time frame:Baseline and up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in Urobilinogen

Time frame:Baseline and up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in ECG Parameters

Time frame:Baseline and Up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Change From Baseline in ECG Mean Heart Rate

Time frame:Baseline and Up to Day 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Part 2: Ctrough of TB006

Time frame:Day 29

descriptive

Secondary/protocol endpoint/low confidence

Part 2: t1/2 of TB006

Time frame:Day 29

descriptive

Secondary/registry result/low confidence

Part 2: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), International Units per Liter	Standard deviation
Part 2: TB006 1000 mg qwALTn=58 Participants	-0.5	12.88
ALPn=58 Participants	1.0	12.01
ASTn=58 Participants	-0.4	10.44
CKn=58 Participants	-14.3	77.24
Part 2: PlaceboALTn=64 Participants	-0.4	5.40
ALPn=64 Participants	0.0	11.92
ASTn=64 Participants	-0.5	3.58
CKn=64 Participants	6.3	52.07

Secondary/registry result/low confidence

Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), grams per deciliter	Standard deviation
Part 2: TB006 1000 mg qwAlbuminn=58 Participants	-0.10	0.300
Proteinn=58 Participants	-0.10	0.470
Part 2: PlaceboAlbuminn=64 Participants	-0.01	0.251
Proteinn=64 Participants	0.00	0.404

Secondary/registry result/low confidence

Part 2: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL Cholesterol, LDL Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), milligrams per deciliter	Standard deviation
Part 2: TB006 1000 mg qwCalciumn=58 Participants	-0.09	0.437
Cholesteroln=58 Participants	-5.8	32.30
Creatininen=58 Participants	0.014	0.098
Direct Bilirubinn=58 Participants	0.005	0.037
Glucosen=58 Participants	-5.6	26.98
HDL Cholesteroln=58 Participants	-2.4	8.49
LDL Cholesteroln=58 Participants	-7.5	24.64
Total Bilirubinn=58 Participants	0.023	0.157
Triglyceridesn=58 Participants	-9.2	73.95
Urea Nitrogenn=58 Participants	0.41	3.817
Part 2: PlaceboCalciumn=64 Participants	-0.11	0.432
Cholesteroln=64 Participants	0.3	28.17
Creatininen=64 Participants	-0.017	0.124
Direct Bilirubinn=64 Participants	-0.006	0.030
Glucosen=64 Participants	-6.3	27.92
HDL Cholesteroln=64 Participants	-0.3	8.26
LDL Cholesteroln=64 Participants	-4.6	23.63
Total Bilirubinn=64 Participants	-0.014	0.128
Triglyceridesn=64 Participants	-0.4	46.29
Urea Nitrogenn=64 Participants	-1.03	4.777

Secondary/registry result/low confidence

Part 2: Change From Baseline in Clinical Chemistry Parameter: Hemoglobin A1C

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), percentage of glycosylated hemoglobin	Standard deviation
Part 2: TB006 1000 mg qwn=54 Participants	-0.06	0.638
Part 2: Placebon=63 Participants	0.07	0.555

Secondary/registry result/low confidence

Part 2: Change From Baseline in Clinical Chemistry Parameters: Potassium and Sodium

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), Millimoles per liter	Standard deviation
Part 2: TB006 1000 mg qwPotassiumn=58 Participants	-0.14	0.469
Sodiumn=58 Participants	-0.7	2.11
Part 2: PlaceboPotassiumn=64 Participants	-0.13	0.521
Sodiumn=64 Participants	-0.7	3.05

Secondary/registry result/low confidence

Part 2: Change From Baseline in Clinical Chemistry Parameter: Thyrotropin

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), micro-international units per milliliter	Standard deviation
Part 2: TB006 1000 mg qwn=58 Participants	-0.118	0.619
Part 2: Placebon=64 Participants	0.134	1.000

Secondary/registry result/low confidence

Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), 10^3 cells per microliter	Standard deviation
Part 2: TB006 1000 mg qwBasophilsn=58 Participants	-0.004	0.027
Eosinophilsn=58 Participants	-0.008	0.113
Leukocytesn=58 Participants	-0.26	1.383
Lymphocytesn=58 Participants	-0.118	0.392
Monocytesn=58 Participants	-0.021	0.109
Neutrophilsn=58 Participants	-0.109	1.295
Plateletsn=57 Participants	-1.9	32.08
Part 2: PlaceboBasophilsn=63 Participants	-0.002	0.022
Eosinophilsn=63 Participants	-0.040	0.130
Leukocytesn=63 Participants	-0.02	1.244
Lymphocytesn=63 Participants	-0.053	0.411
Monocytesn=63 Participants	0.003	0.107
Neutrophilsn=63 Participants	0.067	1.206
Plateletsn=61 Participants	-12.1	46.27

Secondary/registry result/low confidence

Part 2: Change From Baseline in Hematology Parameter: Ery. MCH

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), picograms	Standard deviation
Part 2: TB006 1000 mg qwn=58 Participants	0.19	0.775
Part 2: Placebon=63 Participants	0.51	1.045

Secondary/registry result/low confidence

Part 2: Change From Baseline in Hematology Parameter: Ery. MCV

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), femtoliters	Standard deviation
Part 2: TB006 1000 mg qwn=58 Participants	1.54	2.743
Part 2: Placebon=63 Participants	2.04	3.412

Secondary/registry result/low confidence

Part 2: Change From Baseline in Hematology Parameter: Erythrocytes and Reticulocytes

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), 10^6 cells per microliter	Standard deviation
Part 2: TB006 1000 mg qwErythrocytesn=58 Participants	-0.028	0.269
Reticulocytesn=58 Participants	0.001	0.012
Part 2: PlaceboErythrocytesn=63 Participants	0.024	0.228
Reticulocytesn=63 Participants	-0.003	0.012

Secondary/registry result/low confidence

Part 2: Change From Baseline in Hematology Parameter: Hematocrit

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), Percentage	Standard deviation
Part 2: TB006 1000 mg qwn=58 Participants	0.41	2.735
Part 2: Placebon=63 Participants	1.11	2.403

Secondary/registry result/low confidence

Part 2: Change From Baseline in Hematology Parameter: Hemoglobin

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), grams per deciliter	Standard deviation
Part 2: TB006 1000 mg qwn=58 Participants	0.00	0.766
Part 2: Placebon=63 Participants	0.29	0.827

Secondary/registry result/low confidence

Part 2: Change From Baseline in Urine pH

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), potential of Hydrogen	Standard deviation
Part 2: TB006 1000 mg qwn=57 Participants	-0.13	0.788
Part 2: Placebon=61 Participants	0.18	0.791

Secondary/registry result/low confidence

Part 2: Change From Baseline in Urine Specific Gravity

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), Ratio	Standard deviation
Part 2: TB006 1000 mg qwn=57 Participants	0.002	0.010
Part 2: Placebon=61 Participants	0.001	0.008

Secondary/registry result/low confidence

Part 2: Change From Baseline in Urobilinogen

Time frame:Baseline and up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), milligrams per deciliter	Standard deviation
Part 2: TB006 1000 mg qwn=57 Participants	0.07	0.313
Part 2: Placebon=61 Participants	0.05	0.354

Secondary/registry result/low confidence

Part 2: Change From Baseline in ECG Parameters

Time frame:Baseline and Up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), milliseconds	Standard deviation
Part 2: TB006 1000 mg qwPR Intervaln=57 Participants	-1.6	13.17
QRS Durationn=58 Participants	-2.2	13.31
QT Intervaln=58 Participants	4.2	26.29
QTcB Intervaln=58 Participants	-2.0	18.01
Part 2: PlaceboPR Intervaln=63 Participants	2.1	18.32
QRS Durationn=63 Participants	-1.4	7.71
QT Intervaln=63 Participants	3.9	20.28
QTcB Intervaln=63 Participants	-1.7	15.99

Secondary/registry result/low confidence

Part 2: Change From Baseline in ECG Mean Heart Rate

Time frame:Baseline and Up to Day 104

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute	Standard deviation
Part 2: TB006 1000 mg qwn=58 Participants	-1.8	8.87
Part 2: Placebon=63 Participants	-1.3	7.40

Secondary/registry result/low confidence

Part 2: Ctrough of TB006

Time frame:Day 29

descriptive

Posted result

Group	Value (geometric_mean), micrograms per milliliter	Geometric coefficient of variation
Part 2: TB006 1000 mg qwn=59 Participants	395.82	35.88

Secondary/registry result/low confidence

Part 2: t1/2 of TB006

Time frame:Day 29

descriptive

Posted result

Group	Value (geometric_mean), hours	Geometric coefficient of variation
Part 2: TB006 1000 mg qwn=48 Participants	756.78	22.05

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.