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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Alzheimer's Disease; Healthy Participants

Treatments: Drug: BMS-986446

Study type: Interventional

Funder types: Industry

Identifiers

NCT07780383

CN008-0028

Details and patient eligibility

About

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

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 6 patient groups

Panel A1: BMS986446

Experimental group

Treatment:

Drug: BMS-986446

Panel A2: BMS986446

Experimental group

Treatment:

Drug: BMS-986446

Panel A3: BMS986446

Experimental group

Treatment:

Drug: BMS-986446

Panel B1: BMS986446

Experimental group

Treatment:

Drug: BMS-986446

Panel B2: BMS986446

Experimental group

Treatment:

Drug: BMS-986446

Panel C1: BMS986446

Experimental group

Treatment:

Drug: BMS-986446