A Trial to Compare What the Body Does to Selatogrel and the Effect of Selatogrel in Chinese Adults With Chronic Coronary Syndrome

Sponsor
Viatris Innovation GmbH
Study ID
NCT07615868
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Chronic Coronary Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Selatogrel — COMBINATION_PRODUCT
    Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. A single dose of 16 mg selatogrel will be administered as a liquid formulation from a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system.
  • Matching placebo — COMBINATION_PRODUCT
    A single dose of placebo will be administered as a liquid formulation from a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system.

Study Details

The purpose of this study is to evaluate the pharmacokinetics (PK), pharmacodynamics, and tolerability of a single dose of selatogrel in Chinese adults with chronic coronary syndrome. Pharmacokinetics is the study of the absorption and breakdown of the study drug in the body. Pharmacodynamics is the study of the effect of the study drug on the body. Researchers will compare selatogrel to a placebo (a look-alike substance that contains no drug). Participants will stay at the research clinic for 3 or 4 days (2 or 3 nights), during which time they will receive a single dose of selatogrel or placebo. A telephone call for post-trial safety follow-up will be done 30-40 days after the participant leaves the clinic.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Selatogrel
    Study treatment is administered in the morning as a subcutaneous single dose.
  • Placebo Comparator: Placebo
    Study treatment is administered in the morning as a subcutaneous single dose.

Primary Outcome Measure

Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) [ Time Frame: Up to 36 hours post-dose ]