NCT01588132

Anfibatide Phase 1 Clinical Trial in Healthy Volunteers

First Assessment of the Glycoprotein Ib-IV-V Complex Antagonist Anfibatide in Healthy Human Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 28 Years
• Healthy volunteers: Accepted

Summary

In this 94 healthy subjects Phase I clinical trial, we assess the clinical profile of Anfibatide, a specific glycoprotein Ib antagonist. This study represents the first clinical evidence that Anfibatide exhibits strong anti-platelet effects, excellent reversibility, and low bleeding potential in healthy human subjects.

Conditions

• Coronary Heart Disease
• Coagulation Disorder

Interventions

Type	Name	Description
DRUG	Anfibatide	1. To investigate the safety and tolerability of single intravenous dose of Antiplatelet Thrombolysin for Injection of 0.33,0.66,1.0,1.5,2.0,3.0,4.0,5.0μg (body weight 60kg) in healthy volunteers. 2. To investigate the safety and tolerability of continuous administration of three dose regimen: ① give intravenous injection of 3μg as the first dose and after 1.5 hours, infusion of the study product 0.12μg/h for 24 hours. ② give intravenous injection of 3μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours. ③ give intravenous injection of 5μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2012-04-30
• Last updated: 2012-04-30