NCT05251090

A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII ，Fc Fusion Protein for Injection

A Phase I, Multicentre, Open-label Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection in Children With Severe Hemophilia A

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Jiangsu Gensciences lnc. · Industry
• Sex: Male
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
DRUG	ADVATE	50 international units (IU)/kg, a single dose.
DRUG	FRSW107	50 IU/kg, a single dose.

Timeline

• Start date: 2021-06-16
• Primary completion: 2021-11-15
• Completion: 2022-05-09
• First posted: 2022-02-22
• Last updated: 2023-08-22

Locations

6 sites across 1 country: China