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.
- Alzheimer's Disease
- Healthy Participants
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Bristol-Myers Squibb
- Enrolment target
- 84
- Started
- 21 August 2026
- Main results due
- 17 June 2027
- Study sites
- 6
- Registry updated
- 24 September 2026
Can you take part?
- Ages 18 years to 80 years.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
The purpose of this study is 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
Study sites(6)
CenExel ACT (Formerly Anaheim Clinical Trials; LLC)
Anaheim, California, United States
Recruiting
Local Institution - 0003
Bradenton, Florida, United States
Not yet recruiting
Local Institution - 0005
Daytona Beach, Florida, United States
Not yet recruiting
Local Institution - 0007
Naples, Florida, United States
Not yet recruiting
Local Institution - 0006
The Villages, Florida, United States
Not yet recruiting
Local Institution - 0004
Decatur, Georgia, United States
Not yet recruiting
Showing 6 of 6 sites. 1 of the 6 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07780383. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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