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

Staidson Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hemophilia

Treatments: Drug: STSP-0601 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04747964

STSP-0601-01

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 6 patient groups

A single lowest dose of treatment group

Experimental group

Treatment:

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

A single low dose of treatment group

Experimental group

Treatment:

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

A single low-intermediate dose of treatment group

Experimental group

Treatment:

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

A single intermediate dose of treatment group

Experimental group

Treatment:

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

A single high dose of treatment group

Experimental group

Treatment:

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

A single highest dose of treatment group

Experimental group

Treatment:

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection

Drug: STSP-0601 for Injection