drugset
drugset / Trial / NCT04864743

A Study to Evaluate the Pharmacokinetics，Safety and Tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection

NCT04864743 ↗

Phase 1 Completed 13 enrolled Hangzhou Gensciences Biopharmaceutical Co., Ltd.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objectives of the study are to evaluate the Pharmacokinetics，Safety and tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW117) in patients with severe hemophilia A. The secondary objectives are to monitor anti-durg antibodies and anti-PEG antibodies levels in patients with severe hemophilia A

Timeline

Start
2021-06-22
Primary completion
2021-10-17
Completion
2021-10-17

Drugs

EvaluationDrugModalityDoseRoute
Subject ADVATE Protein / enzyme biologic 25 iu/kg —
Subject ADVATE Protein / enzyme biologic 50 iu/kg —
Subject FRSW117 Protein / enzyme biologic 25 iu/kg —
Subject FRSW117 Protein / enzyme biologic 50 iu/kg —

Indications

severe hemophilia A