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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05517837
• Other study ID #: IM052-004
• Status: Terminated
• Phase: Early Phase 1
• Start date: September 13, 2022
• Est. completion date: July 14, 2023

Study information

• Verified date: September 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: July 14, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986421
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)		Up to 8 Weeks
Primary	Number of participants with physical examination abnormalities		Up to 8 Weeks
Primary	Number of participants with vital sign abnormalities		Up to 8 Weeks
Primary	Number of participants with electrocardiogram (ECG) abnormalities		Up to 8 Weeks
Primary	Number of participants with clinical laboratory abnormalities		Up to 8 Weeks
Secondary	Maximum observed plasma concentration (Cmax)		Up to 192 hours after each dose
Secondary	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
Secondary	Time of maximum observed plasma concentration (Tmax)		Up to 192 hours after each dose

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting