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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Beijing Children's Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Shenzhen Children's Hospita
Shenzhen, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangzhou, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Maximum measured concentration of FVIII:C (Cmax)
Measured by aPTT Clotting Assay.
Time frame: Pre-dose and post dose up to 8 days.
Time required for the concentration of the drug to reach half of its original value (T1/2)
Measured by aPTT Clotting Assay.
Time frame: Pre-dose and post dose up to 8 days
Area Under the Curve to Infinity (AUC)
Measured by aPTT Clotting Assay.
Time frame: Pre-dose and post dose up to 8 days.
The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time (CL).
Measured by aPTT Clotting Assay.
Time frame: Pre-dose and post dose up to 8 days.
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0.
Adverse events related to Recombinant Human Coagulation Factor VIII-Fc fusion protein for Injection according to Common Terminology Criteria for Adverse Events (CTCAE) NCI.V5.0.
Time frame: Post dose up to 32 days.
Development of Inhibitor
Measured by the Nijmegen-Modified Bethesda Assay.
Time frame: Pre-dose and post dose up to 32 days.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China