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Recruiting

Trial ID CV028-1001  |   NCT05806359

A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-55
    Age Range
  • 1
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to assess the safety, tolerability, and single-dose pharmacokinetics of danicamtiv in healthy Japanese and Caucasian participants.

Nearest Recruiting Site

Key Eligibility Criteria

Inclusion Criteria: - Body mass index between 18 and 30 kilograms/meter squared inclusive, at the screening visit. - Japanese participants must be of Japanese descent (both biological parents are ethnically Japanese). - Caucasian participants must be of European or Latin American Caucasian descent. - A female participant is eligible to participate if she is a woman of nonchildbearing potential as defined in the protocol. - Males who are sexually active with woman of childbearing potential must agree to follow protocol-defined instructions for method(s) of contraception. Exclusion Criteria: - Any acute or chronic medical illness. - Active infection, including with coronavirus disease-19, diagnosed clinically by the investigator. - History of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or sponsor clinical trial physician, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. Note: Other protocol-defined inclusion/exclusion criteria apply.

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Caucasian Cohort - Dose 3

ASSIGNED INTERVENTION
  • Drug: Placebo, Danicamtiv

Study Arms

Experimental: Japanese Cohort - Dose 1

ASSIGNED INTERVENTION
  • Drug: Placebo, Danicamtiv

Study Arms

Experimental: Japanese Cohort - Dose 2

ASSIGNED INTERVENTION
  • Drug: Placebo, Danicamtiv

Study Arms

Experimental: Japanese Cohort - Dose 3

ASSIGNED INTERVENTION
  • Drug: Placebo, Danicamtiv
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Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com