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

August 19, 2026 updated by: Bristol-Myers Squibb

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Local Institution - 0001
        • Contact:
          • Site 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Panel A1: BMS986446
Drug: BMS-986446
Specified dose on specified days
Other Names:
  • PRX005
  • Moponetug
Experimental: Panel A2: BMS986446
Drug: BMS-986446
Specified dose on specified days
Other Names:
  • PRX005
  • Moponetug
Experimental: Panel A3: BMS986446
Drug: BMS-986446
Specified dose on specified days
Other Names:
  • PRX005
  • Moponetug
Experimental: Panel B1: BMS986446
Drug: BMS-986446
Specified dose on specified days
Other Names:
  • PRX005
  • Moponetug
Experimental: Panel B2: BMS986446
Drug: BMS-986446
Specified dose on specified days
Other Names:
  • PRX005
  • Moponetug
Experimental: Panel C1: BMS986446
Drug: BMS-986446
Specified dose on specified days
Other Names:
  • PRX005
  • Moponetug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Up to approximately 5 months
Maximum observed concentration (Cmax)
Time Frame: Up to approximately 5 months
Up to approximately 5 months
Time of maximum observed concentration (Tmax)
Time Frame: Up to approximately 5 months
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
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
Up to approximately 5 months
AUC(INF)
Time Frame: Up to approximately 5 months
Up to approximately 5 months
Half-life (T-HALF)
Time Frame: Up to approximately 5 months
Up to approximately 5 months
Apparent total body clearance in SC administration (CLT/F)
Time Frame: Up to approximately 5 months
Up to approximately 5 months
Total body clearance in IV infusion (CLT)
Time Frame: Up to approximately 5 months
Up to approximately 5 months
Apparent volume of distribution of terminal phase in SC administration (Vz/F)
Time Frame: Up to approximately 5 months
Up to approximately 5 months
Volume of distribution of terminal phase (VZ)
Time Frame: Up to approximately 5 months
Up to approximately 5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AEs)
Time Frame: Up to approximately 5 months
Up to approximately 5 months
Serious adverse events (SAEs)
Time Frame: Up to approximately 5 months
Up to approximately 5 months
AEs reported as related to BMS-986446
Time Frame: Up to approximately 5 months
Up to approximately 5 months
Incidence of anti-drug antibody (ADA)
Time Frame: Up to approximately 5 months
Up to approximately 5 months
Local tolerance evaluation
Time Frame: Up to approximately 5 months
This evaluation will assess pain, itching, burning, pressure, and soreness/tenderness (using a Numeric Rating Scale) at the injection site location.
Up to approximately 5 months
GMR of Panel B1 vs Panel A3 for Cmax
Time Frame: Up to approximately 5 months
Up to approximately 5 months
GMR of Panel B1 vs Panel A3 for area under the concentration-time curve (AUC)
Time Frame: Up to approximately 5 months
Up to approximately 5 months
GMR of Panel B2 vs Panel A3 for Cmax
Time Frame: Up to approximately 5 months
Up to approximately 5 months
GMR of Panel B2 vs Panel A3 for AUC
Time Frame: Up to approximately 5 months
Up to approximately 5 months
Cmax
Time Frame: Up to approximately 5 months
Panel B1, Panel B2, Panel C1
Up to approximately 5 months
Tmax
Time Frame: Up to approximately 5 months
Panel B1, Panel B2, Panel C1
Up to approximately 5 months
AUC(0-T)
Time Frame: Up to approximately 5 months
Panel B1, Panel B2
Up to approximately 5 months
AUC(0-672)
Time Frame: Up to approximately 5 months
Panel B1, Panel B2
Up to approximately 5 months
AUC(INF)
Time Frame: Up to approximately 5 months
Panel B1, Panel B2
Up to approximately 5 months
T-HALF
Time Frame: Up to approximately 5 months
Panel B1, Panel B2, Panel C1
Up to approximately 5 months
CLT/F
Time Frame: Up to approximately 5 months
Panel B1, Panel B2, Panel C1
Up to approximately 5 months
Vz/F
Time Frame: Up to approximately 5 months
Panel B1, Panel B2, Panel C1
Up to approximately 5 months
Trough observed plasma concentration (Ctrough)
Time Frame: Up to approximately 5 months
Panel C1
Up to approximately 5 months
Concentration at the end of a dosing interval (Ctau)
Time Frame: Up to approximately 5 months
Panel C1
Up to approximately 5 months
Area under the concentration-time curve within a dosing interval (AUC(TAU))
Time Frame: Up to approximately 5 months
Panel C1
Up to approximately 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 21, 2026

Primary Completion (Estimated)

June 17, 2027

Study Completion (Estimated)

June 17, 2027

Study Registration Dates

First Submitted

August 19, 2026

First Submitted That Met QC Criteria

August 19, 2026

First Posted (Actual)

August 21, 2026

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN008-0028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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