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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

NCT ID: NCT07780383
Registry status: Recruiting
Study type: Interventional
Phase: Phase 1
Sponsor: Bristol-Myers Squibb
Conditions: Alzheimer's Disease, Healthy Participants

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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.

Enrollment: 84 participants (Estimated).

What is being studied

Drug: BMS-986446

Who may be eligible

Ages: 18 Years to 80 Years
Sex: All
Healthy volunteers accepted: Yes

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

6 study locations are listed.

Recruiting site status is explicitly provided for 6 locations; 1 is listed as Recruiting.

Countries: United States

California, United States: 1
Florida, United States: 4
Georgia, United States: 1

Sample of listed locations

CenExel ACT (Formerly Anaheim Clinical Trials; LLC) — Anaheim, California, 92801, United States — Recruiting
Local Institution - 0003 — Bradenton, Florida, 34205, United States — Not yet recruiting
Local Institution - 0005 — Daytona Beach, Florida, 32117, United States — Not yet recruiting
Local Institution - 0007 — Naples, Florida, 34105, United States — Not yet recruiting
Local Institution - 0006 — The Villages, Florida, 32162, United States — Not yet recruiting
Local Institution - 0004 — Decatur, Georgia, 30030, United States — Not yet recruiting

Study details

Start date: August 21, 2026
Primary completion date: June 17, 2027
Completion date: June 17, 2027
First posted: August 21, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07780383
Registry last updated: September 24, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT07780383 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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