Objective:To determine pharmacokinetics (PK), safety and tolerability of a double-chain recombinant human factor VIII-Fc fusion protein (FRSW107) in previously treated patients (PTPs) in clinical trial which was registered at www.clinicaltrials.gov as NCT03747653 and scheduled to finish at end of July, 2019. Methods:At least 12 PTPs (12 to 60 years old) with FVIII:C<2% and without history of FVIII inhibitors received a single dose of rFVIII (Advate) at 25 or 65 IU/kg followed by an equal dose of FRSW107. Results: Up-on the data from 7 subjects received 25 IU/kg , the geometric mean t1/2 of FRSW107 was 26.23 hours. This represents a 1.98-fold improvement over that of rFVIII (13.34 hours) at equivalent doses. All adverse events were unrelated to study drug. None of the study subjects developed FVIII inhibitors. Conclusion:According to the preliminary data from this phase 1 clinical trial, FRSW107 shows a significantly extended half- life compared to control FVIII while no safety issue identified.
No relevant conflicts of interest to declare.
Author notes
Asterisk with author names denotes non-ASH members.
