RecruitingPhase 1

A Study to Evaluate the Drug Levels, Absolute Bioavailability, Safety, Tolerability, and Immunogenicity of Single-Dose of BMS-986446 in Healthy Adults After Single-dose Administration, and Participants With Early Alzheimer's Disease After Multiple Dose Administration

A Phase 1, Open-label, Multi-part Study to Evaluate Pharmacokinetics, Absolute Bioavailability, Safety, Tolerability, and Immunogenicity of Single-Dose of BMS-986446 Following Intravenous and Subcutaneous Administrations in Healthy Adults and Multiple Doses of BMS-986446 in Participants With Early Alzheimer's Disease.

Lead sponsor

Bristol-Myers Squibb

Asset

BMS-986446

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•mild AD dementia•MMSE 20-28

Primary endpoints

•Absolute bioavailability estimated from geometric mean ratio (GMR) of AUC•Absolute bioavailability estimated from GMR of AUC(INF) of BMS-986446 after•Cmax

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 IDCN008-0028

NCT IDNCT07780383

Timeline

Milestones

Study first posted2026-08-21actual

Study start2026-08-21actual

Last update posted2026-09-24actual

Primary completion2027-06-17estimated

Study completion2027-06-17estimated

Assets

Drug assets

BMS-986446

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Participants must have a BMI of 18.0 to 35.0 kg/m2.

•For Parts A and B: Participants must be healthy as determined by medical history, Physical Examination (PE), neurological examination, vital signs, 12-lead ECG, Columbia Suicide-Severity Rating Scale (C-SSRS), and clinical laboratory evaluations.

•For Part C: Participants must meet diagnostic criteria for MCI or mild AD dementia, consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) diagnostic criteria.

•For Part C: Participants must have an Mini Mental State Examination (MMSE) score of ≥ 20 to 28 (inclusive).

•For Part C: Participants must have evidence of positive plasma pTau217

Exclusion criteria

•For Parts A and B: Participants must not have a general history of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, immune-mediated disorder, hematological, ongoing allergic disorder requiring treatment, metabolic disorder, cancer, or cirrhosis.

•For Parts A and B: Participants must not have donated or lost 500 mL blood or more within 60 days prior to study intervention administration.

•For Part C: Participants must not have a neurological condition that in the opinion of the investigator may be contributing to cognitive impairment aside from the AD diagnosis, including but not limited to: Parkinson's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, long COVID, or baseline intellectual disability.

•For Part C: Participants must not have any current primary psychiatric diagnosis (eg, major depression, schizoaffective disorder or bipolar disorder) other than AD or symptoms (eg, hallucination or delusions).

•Other protocol-defined Inclusion/Exclusion criteria apply.

Endpoints (32)

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

Other (unclassified)

Safety / tolerability / PK

21 endpoints

Primary/protocol endpoint

Absolute bioavailability estimated from geometric mean ratio (GMR) of area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986446 after subcutaneous (SC) infusion