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

NCT06084598 | Completed Phase 1 FDA Drug

• 1 other identifier: CN008-0016
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

Pharmacokinetics; Healthy Participants; Healthy Japanese Participants; BMS-986446; PRX005

Outcome Measures

Primary Outcomes (6)

• Incidence of adverse events (AEs)

  Up to Day 85

• Number of participants with vital sign 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 body weight abnormalities

  Up to Day 85

• Number of participants with clinical laboratory abnormalities

  Up to Day 85

Secondary Outcomes (7)

• Maximum observed plasma concentration (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

• Number of participants with anti-drug antibody (ADA)

  Up to Day 85

• Geometric mean ratios of Cmax

  Up to Day 85

Study Arms (2)

BMS-986446

EXPERIMENTAL

Drug: BMS-986446

Placebo

EXPERIMENTAL

Other: Placebo

Interventions

BMS-986446 DRUG

Specified dose on specified days

BMS-986446

Placebo OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

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: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start: October 12, 2023
• Primary Completion: March 8, 2024
• Study Completion: March 8, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)