The first subject has been enrolled and administrated with SR604 in United States in the Phase 1 study of SR604 (NCT06349473), a clinical trial being conducted following approvals of the Investigational New Drug (IND) Application by the U.S. FDA. The clinical trial program started with enrollment of healthy participants and will expand to participants with Hemophilia A or Hemophilia B, with or without inhibitors.
The single ascending dose portion of the Phase 1 clinical study (Part A) is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SR604 in healthy participants. The multiple ascending dose portion of the Phase 1 clinical study (Part B) is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SR604 in participants with Hemophilia A or Hemophilia B.
May 10, 2024