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NOT YET RECRUITING
NCT07887490
PHASE1

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Recombinant Anfibatide Injection in Healthy Volunteers

Sponsor: Lee's Pharmaceutical Limited

View on ClinicalTrials.gov

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

Interventions

DRUG

Recombinant Anfibatide Injection

Recombinant Anfibatide Injection is a polypeptide antithrombotic agent. Administered as a single intravenous bolus injection over approximately 5 minutes.

OTHER

Placebo

Matching placebo injection

Locations (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China