Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor

This study will assess the safety,efficacy,pharmacokinetics and pharmacodynamics of multiple-dose of STSP-0601 at two dose levels for the treatment of bleeding episodes in hemophilia A or B patients without inhibitor.

Inclusion Criteria:18 ≤age≤70 years of age,male;Hemophilia A or B patients;A bleeding event requiring treatment occurred (Only applicable to the on-demand treatment stage);Factor VIII or IX level <2%, inhibitor titer < 0.6 BU;There were at least 2 bleeding events that requiring treatment occurred in the past 6 months before screening (Only the second stage is applicable);Establish proper venous access;Agree to use adequate contraception to avoid pregnancy;Provide signed informed consent.Exclusion Criteria:Have any coagulation disorder other than hemophilia;Plan to receive prophylactic treatment of coagulation factor during the trail;4 weeks before screening, receive prophylactic treatment of amesetuzumab or plan to receive prophylactic treatment of amesetuzumab during the trial;Patients received anticoagulant or antifibrinolytic therapy 7 days before enrollment or plan to receive these drugs during the trial;Patients received anticoagulation therapy (such as coagulation factor replacement therapy, prothrombin complex, plasma, etc.) 7 days before enrollment;Have a history of arterial and/or venous thrombotic events;Platelet <100×109/L;Hemoglobin<90g/L;Severe liver or kidney disease;Severe bleeding event occurred within 4 weeks before enrollment;Accepted major operation or blood transfusion within 4 weeks before enrollment;HIV positive;Have a known allergy to STSP-0601;Participate in other clinical research within 4 weeks before enrollment(except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails);Patients not suitable for the trail according to the judgment of the investigators.