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

NCT07780383 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CN008-0028
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (12)

• 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

  Up to approximately 5 months

• Absolute bioavailability estimated from GMR of AUC(INF) of BMS-986446 after intravenous (IV) infusion

  Up to approximately 5 months

• Maximum observed concentration (Cmax)

  Up to approximately 5 months

• Time of maximum observed concentration (Tmax)

  Up to approximately 5 months

• Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

  Up to approximately 5 months

• Area under the serum concentration-time curve from time zero to 672 hours (AUC(0-672))

  Up to approximately 5 months

• AUC(INF)

  Up to approximately 5 months

• Half-life (T-HALF)

  Up to approximately 5 months

• Apparent total body clearance in SC administration (CLT/F)

  Up to approximately 5 months

• Total body clearance in IV infusion (CLT)

  Up to approximately 5 months

• Apparent volume of distribution of terminal phase in SC administration (Vz/F)

  Up to approximately 5 months

• Volume of distribution of terminal phase (VZ)

  Up to approximately 5 months

Secondary Outcomes (20)

• Adverse events (AEs)

  Up to approximately 5 months

• Serious adverse events (SAEs)

  Up to approximately 5 months

• AEs reported as related to BMS-986446

  Up to approximately 5 months

• Incidence of anti-drug antibody (ADA)

  Up to approximately 5 months

• Local tolerance evaluation

  Up to approximately 5 months

Study Arms (6)

Panel A1: BMS986446

EXPERIMENTAL

Drug: BMS-986446

Panel A2: BMS986446

EXPERIMENTAL

Drug: BMS-986446

Panel A3: BMS986446

EXPERIMENTAL

Drug: BMS-986446

Panel B1: BMS986446

EXPERIMENTAL

Drug: BMS-986446

Panel B2: BMS986446

EXPERIMENTAL

Drug: BMS-986446

Panel C1: BMS986446

EXPERIMENTAL

Drug: BMS-986446

Interventions

BMS-986446 DRUG

Specified dose on specified days

Also known as: PRX005, Moponetug

Panel A1: BMS986446; Panel A2: BMS986446; Panel A3: BMS986446; Panel B1: BMS986446; Panel B2: BMS986446; Panel C1: BMS986446

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Anaheim, California, 92801, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

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

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 21, 2026
• Study Start: August 21, 2026
• Primary Completion (Estimated): June 17, 2027
• Study Completion (Estimated): June 17, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (1)