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
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Number of subjects of adverse events
Study Overview
Brief Summary
This study will assess the pharmacokinetics and pharmacodynamics of STSP-0601 at five dose levels. The results will help identify the most optimal doses to treat bleedings in hemophilia patients with inhibitors.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
A single lowest dose of treatment group
Intervention: STSP-0601 for Injection (Drug)
A single low dose of treatment group
Intervention: STSP-0601 for Injection (Drug)
A single low-intermediate dose of treatment group
Intervention: STSP-0601 for Injection (Drug)
A single intermediate dose of treatment group
Intervention: STSP-0601 for Injection (Drug)
A single high dose of treatment group
Intervention: STSP-0601 for Injection (Drug)
A single highest dose of treatment group
Intervention: STSP-0601 for Injection (Drug)
Outcomes
Primary Outcomes
Number of subjects of adverse events
Time Frame: Baseline to Day 8
Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings
Time Frame: Baseline,1 hour,4 hour,48 hour,Day 8
Number of subjects With Significant Abnormal Physical Examination
Time Frame: Baseline to Day 8
Number of subjects of Significant Abnormal Vital Signs Findings
Time Frame: Baseline to Day 8
Number of Participants With Significant Abnormal Laboratory Values
Time Frame: Baseline to Day 8
Secondary Outcomes
- Thrombin production (TG) peak(Baseline to 24 hours)
- Activated partial thromboplastin time(Baseline to 24 hours)