Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B 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.