UnknownPhase 1

A First-in-Human Study to Assess Single Doses of APNmAb005 in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APNmAb005 in Healthy Subjects

Lead sponsor

APRINOIA Therapeutics, LLC

Asset

APNmAb005

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-65

Primary endpoints

•Adverse Events (AEs)•Treatment-emergent AEs (TEAEs)•Serious Adverse Events (SAEs)

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

Org study IDAPNmAb005-101

NCT IDNCT05344989

Timeline

Milestones

Study first posted2022-04-25actual

Study start2022-05-06actual

Last update posted2023-06-15actual

Primary completion2024-03estimated (month precision)

Study completion2024-07estimated (month precision)

Assets

Drug assets

APNmAb005

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Body Mass Index (BMI) of 18.5 to 32 kg/m² inclusive, at screening.

•Female subjects of childbearing potential must use an acceptable method of birth control from screening until at least 90 days after study drug dosing; OR be surgically sterile; OR be postmenopausal. All female subjects must have a negative pregnancy test at screening and before the first dose of the study drug. Female subjects must also agree to refrain from egg donation during the study and for at least 90 days after study drug dosing.

•Male subjects must agree to use a condom when sexually active with a female partner of childbearing potential during the study and for at least 90 days after study drug dosing (or be surgically sterile); OR agree to practice abstinence during the study and for at least 90 days after study drug dosing. Male subjects must also agree to refrain from sperm donation during the study and for at least 90 days after study drug dosing.

•Agree to comply with all protocol requirements.

•Provide written informed consent

Exclusion criteria

•Unable or unwilling to undergo venipuncture or tolerate venous access, or is unable or unwilling to undergo lumbar puncture.

•Has any significant acute or chronic medical illness that would impact the subject's ability to complete all study requirements or impact assessment of study data; or subject as had a clinically significant illness within 30 days prior to study drug dosing.

•Any medical condition or documented history that is a contraindication to lumbar puncture (e.g. bleeding disorder, spinal deformity).

•Positive COVID-19 molecular diagnostic test result at screening or prior to study drug dosing; or subject has known or suspected consequence from prior COVID-19 infection.

•History of cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or oncogenic (with the exception of resected skin basal cell carcinoma) disease within 5 years prior to screening).

NOTE: Subjects with treated stable psychiatric conditions (e.g. anxiety, depression) are not allowed.

•Clinically significant neurological or psychiatric disorder.

•Major surgery, as determined by investigator, within 4 weeks prior to study drug dosing.

•Systolic blood pressure >140 mm Hg and/or diastolic blood pressure >90 mm Hg.

•Received any vaccine or used any prescription or over-the-counter medications (except paracetamol [up to 2 g per day]), including herbal or nutritional supplements, within 14 days prior to study drug dosing.

•Consumed caffeine- or xanthine-containing products within 48 hours prior to study drug dosing.

•Subject is a smoker or has regularly used nicotine or nicotine-containing products (e.g. snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 3 months prior to study drug dosing.

•Subject is involved in vigorous or strenuous physical activity or contact sports within 24 hours prior to study drug dosing.

•Subject has donated blood or blood products >450 mL within 3 months prior to study drug dosing.

Other protocol-defined inclusion/exclusion criteria may apply.

Endpoints (37)

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

Tau biomarkers

Safety / tolerability / PK

Fluid / digital biomarkers

Other (unclassified)

Tau biomarkers

16 endpoints

Secondary/protocol endpoint

Mean Total tau concentration in plasma

Time frame:Thru Day 70

concentration, descriptive

Secondary/protocol endpoint

Mean change in Total tau concentration in plasma

Time frame:Baseline and Day 70

change from baseline, improvement

Secondary/protocol endpoint

Mean Total tau concentration in CSF

Time frame:Thru Day 14

concentration, descriptive

Secondary/protocol endpoint

Mean change in Total tau concentration in CSF

Time frame:Baseline and Day 14

change from baseline, improvement

Secondary/protocol endpoint

Mean p-tau 181 concentration in plasma

Time frame:Thru Day 70

Phosphorylated tau 181 (p-tau181)

concentration, descriptive

Secondary/protocol endpoint

Mean change in p-tau 181 concentration in plasma

Time frame:Baseline and Day 70

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Secondary/protocol endpoint

Mean p-tau 181 concentration in CSF

Time frame:Thru Day 14

Phosphorylated tau 181 (p-tau181)

concentration, descriptive

Secondary/protocol endpoint

Mean change in p-tau 181 concentration in CSF

Time frame:Baseline and Day 14

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Secondary/protocol endpoint

Mean p-tau 217 concentration in plasma

Time frame:Thru Day 70

Phosphorylated tau 217 (p-tau217)

concentration, descriptive

Secondary/protocol endpoint

Mean change in p-tau 217 concentration in plasma

Time frame:Baseline and Day 70

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Secondary/protocol endpoint

Mean p-tau 217 concentration in CSF

Time frame:Thru Day 14

Phosphorylated tau 217 (p-tau217)

concentration, descriptive

Secondary/protocol endpoint

Mean change in p-tau 217 concentration in CSF

Time frame:Baseline and Day 14

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Secondary/protocol endpoint

Mean p-tau 231 concentration in plasma

Time frame:Thru Day 70

concentration, descriptive

Secondary/protocol endpoint

Mean change in p-tau 231 concentration in plasma

Time frame:Baseline and Day 70

change from baseline, improvement

Secondary/protocol endpoint

Mean p-tau 231 concentration in CSF

Time frame:Thru Day 14

concentration, descriptive

Secondary/protocol endpoint

Mean change in p-tau 231 concentration in CSF

Time frame:Baseline and Day 14

change from baseline, improvement

Fluid / digital biomarkers

6 endpoints

Secondary/protocol endpoint

AUC0-t of APNmAb005 in CSF

Time frame:Thru Day 14

concentration, descriptive

Secondary/protocol endpoint

Cmax of APNmAb005 in CSF

Time frame:Thru Day 14

concentration, descriptive

Secondary/protocol endpoint

Tmax of APNmAb005 in CSF

Time frame:Thru Day 14

time to event, event

Secondary/protocol endpoint

t1/2 of APNmAb005 in CSF

Time frame:Thru Day 14

concentration, descriptive

Secondary/protocol endpoint

CL of APNmAb005 in CSF

Time frame:Thru Day 14

descriptive

Secondary/protocol endpoint

Vd of APNmAb005 in CSF

Time frame:Thru Day 14

descriptive

Safety / tolerability / PK

9 endpoints

Primary/protocol endpoint

Number of subjects with Adverse Events (AEs)

Time frame:Day 70

event count, event

Primary/protocol endpoint

Number of subjects with Treatment-emergent AEs (TEAEs)

Time frame:Day 70

event count, event

Primary/protocol endpoint

Number of subjects with Serious Adverse Events (SAEs)

Time frame:Day 70

event count, event

Primary/protocol endpoint

Number of subjects with AEs resulting in Study Discontinuation

Time frame:Day 70

event count, event

Primary/protocol endpoint

Number of participants with Vital Sign Abnormalities

Time frame:Day 70

event count, event

Primary/protocol endpoint

Number of participants with Electrocardiogram (ECG) Abnormalities

Time frame:Day 70

event count, event

Secondary/protocol endpoint

Cmax of APNmAb005 in blood

Time frame:Thru Day 70

concentration, descriptive

Secondary/protocol endpoint

Tmax of APNmAb005 in blood

Time frame:Thru Day 70

time to event, event

Secondary/protocol endpoint

t1/2 of APNmAb005 in plasma

Time frame:Thru Day 70

concentration, descriptive

Other (unclassified)

6 endpoints

Primary/protocol endpoint/low confidence

Number of participants with Clinical Laboratory Abnormalities

Time frame:Day 70

event count, event

Secondary/protocol endpoint/low confidence

AUC0-t of APNmAb005 in plasma

Time frame:Thru Day 70

concentration, descriptive

Secondary/protocol endpoint/low confidence

CL of APNmAb005 in blood.

Time frame:Thru Day 70

descriptive

Secondary/protocol endpoint/low confidence

Vd of APNmAb005 in plasma

Time frame:Thru Day 70

descriptive

Secondary/protocol endpoint/low confidence

Number of participants with ADA formation against APNmAb005

Time frame:Thru Day 70

event count, event

Secondary/protocol endpoint/low confidence

Number of participants with no ADA formation against APNmAb005

Time frame:Thru Day 70

event count, event

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.