drugset / Trial / NCT05251090
A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII ，Fc Fusion Protein for Injection
NaSingle-groupOpen-labelTreatment
Summary
Primary objective: To assess the pharmacokinetics of Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection (FRSW107) Secondary objectives: To assess Safety and Tolerability by monitoring FVIII recovery and adverse events in Severe Hemophilia A.
Timeline
- Start
- 2021-06-16
- Primary completion
- 2021-11-15
- Completion
- 2022-05-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADVATE | Protein / enzyme biologic | 50 iu/kg | — |
| Subject | FRSW107 | Protein / enzyme biologic | 50 iu/kg | — |