A Phase 1, First-in-Human Study of BMS-986421 in Healthy Participants

Early Phase 1

Terminated

• Conditions: Healthy Participants
• Interventions: Drug: BMS-986421; Other: Placebo

• Registration Number: NCT05517837
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to assess the safety and tolerability of BMS-986421 in healthy adult participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Study Start: 2022-09-13
• Primary Completion: 2023-07-14
• Study Completion: 2023-07-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Participants are required to remain in the clinical facility from Day -1 (Part 1) or Day -2 (Part 2) until clinic discharge.
• A negative test for COVID-19, which will be performed in the manner mandated by the clinical site where this study is being conducted, at screening and admission.
• All female participants, Women of Childbearing Potential (WOCBP) and women not of childbearing potential, must have a negative highly sensitive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) at screening and on Day -1 (or Day -2 for Part 2).

Exclusion Criteria

• Participant was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer).
• Vaccination or plans for vaccination with non-live vaccines within 30 days before Day -1 (for Day -2 for Part 2) until the follow-up phone call.
• Donation of blood or blood transfusion within 8 weeks of first study intervention administration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
BMS-986421 Under Fasted Conditions	BMS-986421	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of participants with vital sign abnormalities	Up to 8 Weeks
Number of participants with electrocardiogram (ECG) abnormalities	Up to 8 Weeks
Number of participants with adverse events (AEs)	Up to 8 Weeks
Number of participants with clinical laboratory abnormalities	Up to 8 Weeks
Number of participants with physical examination abnormalities	Up to 8 Weeks

Secondary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	Up to 192 hours after each dose
Area under the plasma concentration-time curve from time zero to time last quantifiable concentration (AUC[0-T])	Up to 192 hours after each dose
Time of maximum observed plasma concentration (Tmax)	Up to 192 hours after each dose

Trial Locations

Locations (1)

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