Anfibatide Phase 1 Clinical Trial in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
Coronary Heart DiseaseCoagulation Disorder
Interventions
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."

Sponsors
All Listed Sponsors
lead

Lee's Pharmaceutical Limited

INDUSTRY