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Phase 1
Age: 18Years - 85Years
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ID07615868

Study to Evaluate How Selatogrel is Processed and Its Effects in Chinese Adults With Chronic Coronary Syndrome Using a Single 16 mg Injection

Led by Viatris Innovation GmbH · Updated on 2026-07-14

20

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating how the body absorbs, processes, and responds to a single dose of selatogrel in Chinese adults with chronic coronary syndrome. This phase 1 study compares selatogrel to a placebo, focusing on pharmacokinetics, pharmacodynamics, and tolerability. The study aims to understand the drugs behavior and effects in this specific population. Participants will receive a single 16 mg dose of selatogrel or placebo administered subcutaneously in the morning using a prefilled syringe autoinjector. They will stay at the research clinic for 3 to 4 days 2 or 3 nights during which the study drug or placebo is given and closely monitored. After leaving the clinic, a safety follow-up will be conducted by phone 30 to 40 days later. During the clinic stay, participants will undergo blood tests to measure drug levels and effects up to 36 hours after dosing. Researchers will assess the drugs concentration in plasma, the time taken to reach maximum levels, and its half-life. Safety and tolerability will also be monitored throughout the study and during the follow-up call. The total participation time includes the inpatient period plus the post-trial safety check.

CONDITIONS

Brief Title

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

Research Team

V

Viatris Innovation Clinical Trial Information

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