Recruiting

Trial ID CV028-1001 | NCT05806359

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

About This Trial
Key Eligibility Criteria
Trial Site Locations

Summary

Phase 1
18-55

Age Range
1

Locations
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

Take the first step to see if you Match to a Clinical Trial – Check Your Eligibility

Check Your Eligibility

Answer some questions about Your health to see if you may match to this trial

Match to a Trial

If you are a match, click on the study to see the list of study site locations

Select a Study Site Location

Select a study site location that is convenient for you

Provide your contact details for the study site to connect with you.