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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 1

Conditions

Healthy Participants

Treatments

Drug: BMS-986446
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06084598
CN008-0016

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Note: Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

24 participants in 2 patient groups

BMS-986446
Experimental group
Treatment:
Drug: BMS-986446
Placebo
Experimental group
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

BMS Study Connect Contact Center www.BMSStudyConnect.com; First line of the email MUST contain NCT # and Site #.

Data sourced from clinicaltrials.gov

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