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

NCT07852962 — Phase 1, Not yet recruiting, 10 participants, Bristol-Myers Squibb

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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

Registry	NCT07852962
Status	Not yet recruiting
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	10 (Estimated)
Sponsor	Bristol-Myers Squibb (Industry)
Conditions	Healthy Volunteers
Interventions	BMS-986446, Placebo (Drug, other)
Dates	start 2027-02-10 (estimated), primary completion 2027-07-18 (estimated), completion 2027-07-18 (estimated), first posted 2026-10-01, last updated 2026-10-01

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
BMS-986446	Experimental	Drug: BMS-986446
Placebo	Experimental	Other: Placebo

BMS-986446 (Drug), also known as PRX005, Moponetug: Specified dose on specified days
Placebo (Other): Specified dose on specified days

+Outcome measures

Primary outcomes

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

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]

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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.

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb