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Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Recombinant Anfibatide Injection in Healthy Volunteers
Sponsor: Lee's Pharmaceutical Limited
Summary
This is a Phase I, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of Recombinant Anfibatide Injection in healthy adult volunteers. Approximately 36 healthy participants will receive a single intravenous dose of either study drug or matching placebo across sequential dose cohorts. Safety, tolerability, and pharmacokinetic parameters will be assessed following administration.
Official title: A Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of Recombinant Anfibatide Injection After Single Administration in Healthy Adult Subjects
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-11-30
Completion Date
2028-02-15
Last Updated
2026-10-21
Healthy Volunteers
Yes
Conditions
Interventions
Recombinant Anfibatide Injection
Recombinant Anfibatide Injection is a polypeptide antithrombotic agent. Administered as a single intravenous bolus injection over approximately 5 minutes.
Placebo
Matching placebo injection
Locations (1)
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China