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

NCT05517837 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: IM052-004
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Keywords

BMS-986421; Safety; Tolerability; Dose Escalation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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

Study Arms (2)

BMS-986421 Under Fasted Conditions

EXPERIMENTAL

Drug: BMS-986421

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

BMS-986421 DRUG

Specified dose on specified days

BMS-986421 Under Fasted Conditions

Placebo OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Cypress, California, 90630, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: September 13, 2022
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)