NCT04404790

Antiplatelet Thrombolysin (Anfibatide) Phase 1 Clinical Trial in Healthy Volunteers

Phase I Clinical Trial of the Tolerance and Pharmacokinetics of Anfibatide in Health Volunteer

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, dose-escalation, and multidose study, aiming to investigate the tolerability, safety and pharmacokinetics of Anfibatate in healthy subjects. The study is divided into 2 intravenous single groups and 3 continuous administration groups. The dose of Anfibatate from 5 IU/60kg to 7 IU/60kg in intravenous single groups. The dose of Anfibatate from 0.002 IU/kg/h, 0.004 IU/kg/h to 0.008 IU/kg/h in continuous administration groups.

Conditions

• Antiplatelet Drug

Interventions

Type	Name	Description
DRUG	Anfibatide 5 IU/60kg	5 IU/60kg IV administration of Anfibatide with 5 minutes
DRUG	Anfibatide 5 IU/60kg +0.002 IU/kg/h	5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours
DRUG	Anfibatide 5 IU/60kg +0.004 IU/kg/h	5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours
DRUG	Anfibatide 5 IU/60kg +0.008 IU/kg/h	5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours
DRUG	Anfibatide 7 IU/60kg	7 IU/60kg IV administration of Anfibatide with 5 minutes
DRUG	Anfibatide 7 IU/60kg +0.002 IU/kg/h	7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours
DRUG	Anfibatide 7 IU/60kg +0.004 IU/kg/h	7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours
DRUG	Anfibatide 7 IU/60kg +0.008 IU/kg/h	7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-03-01
• Completion: 2021-05-01
• First posted: 2020-05-28
• Last updated: 2020-05-28

Locations

1 site across 1 country: China