drugset / Trial / NCT01588132

Anfibatide Phase 1 Clinical Trial in Healthy Volunteers

NCT01588132 ↗

Phase 1 Completed 94 enrolled Lee's Pharmaceutical Limited
RandomizedSingle-groupTriple-blindTreatment

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.

Timeline

Start
2010-09
Primary completion
2011-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Anfibatide Protein / enzyme biologic 0.0055 ug/kg Intravenous
Subject Anfibatide Protein / enzyme biologic 0.011 ug/kg Intravenous
Subject Anfibatide Protein / enzyme biologic 0.0166667 ug/kg Intravenous
Subject Anfibatide Protein / enzyme biologic 0.025 ug/kg Intravenous
Subject Anfibatide Protein / enzyme biologic 0.0333333 ug/kg Intravenous
Subject Anfibatide Protein / enzyme biologic 0.05 ug/kg Intravenous
Subject Anfibatide Protein / enzyme biologic 0.0666667 ug/kg Intravenous
Subject Anfibatide Protein / enzyme biologic 0.0833333 ug/kg Intravenous
Subject Anfibatide Protein / enzyme biologic 0.12 ug Intravenous