A Study to Assess Drug Levels, Tolerability and Absolute Biological Availability of Single-dose of BMS-986446 in Healthy Participants

September 26, 2025 updated by: Bristol-Myers Squibb

A Phase 1, Randomized, Open-label, Parallel, Single-dose Study to Assess the Pharmacokinetics, Tolerability, and Absolute Bioavailability of Subcutaneous Administration of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in Healthy Participants

The purpose of this study is to assess drug levels, tolerability and absolute biological availability of single subcutaneous dose of BMS-986446 in healthy participants

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

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 Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Local Institution - 0001
      • Anaheim, California, United States, 92801
        • Local Institution - 10000

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 Body Mass Index (BMI) of 18.0 to 30.0 kg/m2.
  • Participants must be healthy as determined by medical history, physical examination, neurological examination, vital signs, 12-lead ECG, C-SSRS, and clinical laboratory evaluations.

Exclusion Criteria:

  • Participants must not have 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.
  • Participants must not have prior exposure to BMS-986446 (PRX005).
  • 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Drug: BMS-986446 IV
Specified dose on specified days was administered intravenously (IV).
Drug: Acetaminophen
Specified dose on specified days
Drug: Loratadine
Specified dose on specified days
Experimental: Arm B
Drug: Acetaminophen
Specified dose on specified days
Drug: Loratadine
Specified dose on specified days
Drug: BMS-986446 SC
Specified dose on specified days was administered subcutaneously (SC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Geometric Mean Ratio (GMR) of Maximum Observed Serum Concentration (Cmax) of BMS-986446 Administered IV versus SC
Time Frame: Up to approximately Day 85
Up to approximately Day 85
GMR of Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986446 Administered IV versus SC
Time Frame: Up to approximately Day 85
Up to approximately Day 85
GMR of Area Under the Serum Concentration-time Curve From Time Zero to 672 Hours (AUC(0-672)) of BMS-986446 Administered IV versus SC
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Absolute Bioavailability (F) Estimated From GMR of AUC(INF) of BMS-986446 Administered as SC versus IV Infusion
Time Frame: Up to approximately Day 85
Up to approximately Day 85

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Number of Participants With AEs Reported Related to BMS-986446
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Number of Participants With Clinically Significant Vital Sign Abnormalities
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Number of Participants With Clinically Significant Physical Examination (PE) Abnormalities
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Number of Participants With Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Cmax of BMS-986446
Time Frame: Up to approximately Day 85
Up to approximately Day 85
AUC(0-T) of BMS-986446
Time Frame: Up to approximately Day 85
Up to approximately Day 85
AUC(0-672) of BMS-986446
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986446
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Time of Maximum Observed Serum Concentration (Tmax) of BMS-986446
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Apparent Terminal Serum Half-life (T-HALF) of BMS-986446
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Total Body Clearance in IV Infusion (CLT) of BMS-986446
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Apparent Total Body Clearance in SC Administration (CLT/F) of BMS-986446
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Volume of Distribution of Terminal Phase in IV Infusion (Vz) of BMS-986446
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Apparent Volume of Distribution of Terminal Phase in SC Administration (Vz/F) of BMS-986446
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Number of Participants With Anti-drug Antibody Development
Time Frame: Up to approximately Day 85
Up to approximately Day 85
Local Tolerance Evaluation SC Administration of BMS-986646 Assessed by Questionnaire
Time Frame: Up to approximately Day 85
Participant-reported response will be obtained using questionnaires that assess for pain (using a Numeric Rating Scale), itching, burning, pressure, and soreness/tenderness at the site injection.
Up to approximately Day 85

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 (Actual)

May 5, 2025

Primary Completion (Actual)

September 11, 2025

Study Completion (Actual)

September 11, 2025

Study Registration Dates

First Submitted

April 25, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

May 2, 2025

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN008-0026

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/disclosure-commitment.htm

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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