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NCT07780383RecruitingPhase 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.

Source: ClinicalTrials.gov · Last updated 24 Sept 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
84 (estimated)
First submitted
19 Aug 2026
Start date
Aug 2026
Primary completion date
Jun 2027
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT07780383

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 84
  • From Aug 2026 to the primary completion date, Jun 2027
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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 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

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CenExel ACT (Formerly Anaheim Clinical Trials; LLC)
Coordinator of this site? Confirm its status
AnaheimUnited StatesRecruiting
-
Coordinator of this site? Confirm its status
BradentonUnited StatesNot yet recruiting
-
Coordinator of this site? Confirm its status
Daytona BeachUnited StatesNot yet recruiting
-
Coordinator of this site? Confirm its status
DecaturUnited StatesNot yet recruiting
-
Coordinator of this site? Confirm its status
NaplesUnited StatesNot yet recruiting
-
Coordinator of this site? Confirm its status
The VillagesUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.