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

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

Official Title
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A Phase 1, Randomized, Multi-Part, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BMS-986421 in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986421
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986421 Under Fasted Conditions<br> | Drug: BMS-986421<br>* Specified dose on specified days<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to 8 Weeks | 
| Number of participants with physical examination abnormalities |  | Up to 8 Weeks | 
| 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 clinical laboratory abnormalities |  | Up to 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986421, Safety, Tolerability, Dose Escalation