A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986446 in Healthy Participants and Healthy Participants of Japanese Ethnicity

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Other: Placebo; Drug: BMS-986446

• Registration Number: NCT06084598
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986446 in healthy participants including healthy participants of Japanese ethnicity.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-10
• Study Start: 2023-10-12
• Study First Posted: 2023-10-16
• Status Verified: 2024-03
• Primary Completion: 2024-03-08
• Study Completion: 2024-03-08
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Participant must be of Japanese ethnicity (both biological parents are ethnically Japanese) for Part 1 and Part 2, Panel 2. No limitations on ethnicity apply to Part 2, Panel 1
• Participant is healthy, without any significant abnormalities in medical history, physical examination, ECGs, or clinical laboratory assessments determinations, as assessed by the investigator
• Body mass index (BMI) of at least 18 kg/m^2 but no more than 32 kg/m^2 at screening
• Body weight between 45 kg and 110 kg

Exclusion Criteria

• Any clinically significant deviation from normal, as judged by the investigator
• Any major surgery within 90 days of study drug administration
• Participation in another interventional clinical trial concurrent with this study

Note: Other protocol-defined inclusion/exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
BMS-986446	BMS-986446	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	Up to Day 85
Number of participants with vital sign abnormalities	Up to Day 85
Number of participants with body weight abnormalities	Up to Day 85
Number of participants with electrocardiogram (ECG) abnormalities	Up to Day 85
Number of participants with physical examination abnormalities	Up to Day 85
Number of participants with clinical laboratory abnormalities	Up to Day 85

Secondary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	Up to Day 85
Number of participants with anti-drug antibody (ADA)	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
Geometric mean ratios of 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 [AUC(0-T)]	Up to Day 85

Trial Locations

Locations (1)

Local Institution - 0001; 🇺🇸 Cypress, California, United States