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

NCT07852962 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CN008-0030
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics; PK; BMS-986446; Healthy Chinese Participants; IV administration

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (8)

• 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

Study Arms (2)

BMS-986446

EXPERIMENTAL

Drug: BMS-986446

Placebo

EXPERIMENTAL

Other: Placebo

Interventions

BMS-986446 DRUG

Specified dose on specified days

Also known as: PRX005, Moponetug

BMS-986446

Placebo OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): February 10, 2027
• Primary Completion (Estimated): July 18, 2027
• Study Completion (Estimated): July 18, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

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