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Recruiting

A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants - CV028-1001

Updated: 13 July, 2023   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18-55

    Age Range

  • 1

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Caucasian Cohort - Dose 3
Drug: Danicamtiv, Placebo
Experimental: Japanese Cohort - Dose 1
Drug: Placebo, Danicamtiv
Experimental: Japanese Cohort - Dose 2
Drug: Placebo, Danicamtiv
Experimental: Japanese Cohort - Dose 3
Drug: Placebo, Danicamtiv

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.

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