Recruiting
Phase 1

BMS-986446

Sponsor:

Bristol-Myers Squibb

Code:

NCT07780383

Conditions

Alzheimer's Disease

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

BMS-986446

Study Details

Brief summary:

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

Conditions

Alzheimer's Disease

Healthy Participants

Study ID

NCT07780383

Start date

Aug 21, 2026

Status verified date

Sep, 2026

Completion date

Jun 17, 2027

Anticipated

Primary completion date

Jun 17, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

84 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Panel A1: BMS986446

experimental: Panel A2: BMS986446

experimental: Panel A3: BMS986446

experimental: Panel B1: BMS986446

experimental: Panel B2: BMS986446

experimental: Panel C1: BMS986446

Interventions

BMS-986446

Specified dose on specified days

Primary outcome measure

  • 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 [ Time Frame: Up to approximately 5 months ]
  • Absolute bioavailability estimated from GMR of AUC(INF) of BMS-986446 after intravenous (IV) infusion [ Time Frame: Up to approximately 5 months ]
  • Maximum observed concentration (Cmax) [ Time Frame: Up to approximately 5 months ]
  • Time of maximum observed concentration (Tmax) [ Time Frame: Up to approximately 5 months ]
  • Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) [ Time Frame: Up to approximately 5 months ]
  • Area under the serum concentration-time curve from time zero to 672 hours (AUC(0-672)) [ Time Frame: Up to approximately 5 months ]
  • AUC(INF) [ Time Frame: Up to approximately 5 months ]
  • Half-life (T-HALF) [ Time Frame: Up to approximately 5 months ]
  • Apparent total body clearance in SC administration (CLT/F) [ Time Frame: Up to approximately 5 months ]
  • Total body clearance in IV infusion (CLT) [ Time Frame: Up to approximately 5 months ]
  • Apparent volume of distribution of terminal phase in SC administration (Vz/F) [ Time Frame: Up to approximately 5 months ]
  • Volume of distribution of terminal phase (VZ) [ Time Frame: Up to approximately 5 months ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

CenExel ACT (Formerly Anaheim Clinical Trials; LLC)

Recruiting

Anaheim, California, United States, 92801

Contacts

Amina Haggag, Site 0001

714-774-7777

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

  • Healthy Participants
  • Early Alzheimer's Disease
  • BMS-986446
  • Subcutaneous Administration
  • IV administration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.