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TB006SAD

CompletedPhase 1

Sequential Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of TB006 in Healthy Subjects

A Phase 1 Double-blind, Randomized, Single Dose, Sequential Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of TB006 in Healthy Subjects

Lead sponsor

TrueBinding, Inc.

Asset

TB006

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Healthy volunteers

Primary endpoints

•Number of subjects and rate of treatment-emergent adverse events•Single-dose PK profile of TB006 in healthy adult subjects•MTD of single doses of TB006 in healthy adult subjects

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 IDNCT04920786

Org study IDTB006HV1101

Timeline

Milestones

Study start2021-06-01actual

Study first posted2021-06-10actual

Primary completion2022-05-03actual

Study completion2022-05-03actual

Last update posted2024-12-09actual

Assets

Drug assets

TB006

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy volunteers, male or female 18-55 at the time of informed consent

•In good health as determined by the principal investigator

•Body weight of ≥ 50 kg and BMI within the range 18-30 kg/m2 (inclusive).

•Chinese subjects are eligible to be included in the study if all of the following criteria apply in addition to the above: Must have been born in China, with 2 Chinese biological parents and 4 Chinese grandparents as confirmed by interview; Must have lived no more than 10 years outside of China; Must not have changed their lifestyle or habits significantly, including diet, since leaving China

Exclusion criteria

•Any current history of clinically significant disease in the opinion of the investigator or receiving maintenance medications on a daily basis.

•Any active or unstable clinically significant medical or psychiatric condition as judged by the investigator.

•Smokes cigarettes or uses other nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers), and has done so in the 3 months prior to screening.

•Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of > 20 units for males or > 16 units for females. One unit is equivalent to 8 glasses of alcohol: a half pint (∼240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.

Endpoints (13)

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

Safety / tolerability / PK

Fluid / digital biomarkers

Other (unclassified)

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

Pharmacokinetic (PK) profile/parameters: Extent of CSF distribution as estimated by TB006 CSF concentrations

Time frame:Through Day 75

concentration, descriptive

Safety / tolerability / PK

11 endpoints

Primary/protocol endpoint

Number of subjects and rate of treatment-emergent adverse events, graded by CTCAE Version 5.0, by dose group and all active treatment vs. placebo

Time frame:Day1-Day 75

event count, event

Primary/protocol endpoint

To determine the single-dose PK profile of TB006 in healthy adult subjects

Time frame:Through day 75

concentration, descriptive

Primary/protocol endpoint

To determine the MTD of single doses of TB006 in healthy adult subjects

Time frame:Through day 75

descriptive

Secondary/protocol endpoint

Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC) through Day 29

Time frame:Through Day 75

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic (PK) profile/parameters: Area under the plasma concentration versus time curve (AUC)

Time frame:Through Day 75

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic (PK) profile/parameters: Maximum observed plasma concentration

Time frame:Through Day 75

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic (PK) profile/parameters: Time at which maximum plasma concentration occurs

Time frame:Through Day 75

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic (PK) profile/parameters: terminal elimination phase half life

Time frame:Through Day 75

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic (PK) profile/parameters: total clearance

Time frame:Through Day 75

descriptive

Secondary/protocol endpoint

Pharmacokinetic (PK) profile/parameters: volume of distribution

Time frame:Through Day 75

descriptive

Secondary/protocol endpoint

Safety and tolerability

Time frame:Through Day 75

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Anti-TB006 antibodies

Time frame:Through Day 75

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.