Study to Assess Drug Levels, Immune Response, Safety and Tolerability of BMS-986446 in Healthy Chinese Participants.

A Phase 1, Double-blind, Randomized, Placebo-controlled, Single-dose Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of BMS-986446 Following Intravenous Administration in Healthy Chinese Participants

The purpose of this study is to assess the drug levels, immune response, safety and tolerability of BMS-986446 in healthy Chinese participants.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Placebo; Drug: BMS-986446

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants must be of Chinese ethnicity (both biological parents are ethnically Chinese).
• Participants must be Healthy adult male and female (as assigned at birth and non-pregnant and non-nursing).
• Participants must have BMI of 18.0 to 28.0 kg/m2.

Exclusion Criteria:

• Participants must not have general history of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, immune-mediated, or hematological disorder; allergic disease; metabolic disorder; cancer; or cirrhosis.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo	Other: Placebo; Specified dose on specified days
Experimental: BMS-986446	Drug: BMS-986446; Specified dose on specified days; Other Names: PRX005; Moponetug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Up to Day 85
Time of maximum observed plasma concentration (Tmax)	Up to Day 85
Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)]	Up to Day 85
Geometric mean ratios of area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]	Up to Day 85
Total body clearance in intravenous infusion (CLT)	Up to Day 85
Volume of distribution of terminal phase in intravenous administration (Vz)	Up to Day 85
Apparent terminal serum half-life [T-HALF]	Up to Day 85

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with anti-drug antibody (ADA) formation	Up to Day 85
Number of participants with adverse events (AEs)	Up to approximately 85 days
Number of participants with vital sign abnormalities	Up to approximately 85 days
Number of participants with 12-lead electrocardiogram (12-lead-ECG) abnormalities	Up to approximately 85 days
Number of participants with physical examination abnormalities	Up to approximately 85 days
Number of participants with body weight abnormalities	Up to approximately 85 days
Number of participants with clinical laboratory abnormalities	Up to approximately 85 days
Number of Participants with Treatment Emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to approximately 85 days

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• <p>BMS Clinical Trial Information</p>
• <p>BMS Clinical Trial Patient Recruiting</p>

Study record dates

Study Major Dates

• Study Start (Estimated): February 10, 2027
• Primary Completion (Estimated): July 18, 2027
• Study Completion (Estimated): July 18, 2027

Study Registration Dates

• First Submitted: September 24, 2026
• First Submitted That Met QC Criteria: September 24, 2026
• First Posted (Actual): October 1, 2026

Study Record Updates

• Last Update Posted (Actual): October 1, 2026
• Last Update Submitted That Met QC Criteria: September 24, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacokinetics; PK; BMS-986446; IV administration; Healthy Chinese Participants
• Other Study ID Numbers: CN008-0030

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 Myer 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
• product manufactured in and exported from the U.S.: Yes