A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor

A Phase 1,Multi-center, Randomized, Open, Single-dose Escalation Design to Evaluate the Safety, Tolerability and Pharmacodynamics of STSP-0601 for Injection in Patients With Inhibitory Hemophilia

This study will assess the pharmacokinetics and pharmacodynamics of STSP-0601 at six dose levels. The results will help identify the most optimal doses to treat bleedings in hemophilia patients with inhibitors.

Inclusion Criteria:

• 18 years old ≤age≤65 years of age,male.
• Hemophilia A or B patients with inhibitors.
• Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
• Establish proper venous access.
• Provide signed informed consent.

Exclusion Criteria:

• Have any coagulation disorder other than hemophilia A or B.
• Treat with prophylactic treatment of coagulation factor.
• Treat with anticoagulant within 7d of the time of study drug administration.
• Have an active, ongoing bleeding for which the patient is being treated, or treatment for a bleeding was stopped within 7d of the time of study drug administration.
• Have a history of arterial and/or venous thromboembolic events.
• Have platelet count <100,000/mL.
• Severe liver or kidney disease.
• Accept major operation or blood transfusion within 1 month of the time of screening.
• HIV antibody positive.
• Have a known allergy to Blood product.
• Participate in other clinical research within 1 month of the time of study drug administration.