Hemophilia
Conditions
Brief summary
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.
Interventions
Subjects will receive one single lowest dose of STSP-0601 for Injection following protocol requirements
Sponsors
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects With Significant Abnormal Physical Examination | Baseline to Day 8 |
| Number of Participants With Significant Abnormal Laboratory Values | Baseline to Day 8 |
| Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings | Baseline,1 hour,4 hour,48 hour,Day 8 |
| Number of subjects of adverse events | Baseline to Day 8 |
| Number of subjects of Significant Abnormal Vital Signs Findings | Baseline to Day 8 |
Secondary
| Measure | Time frame |
|---|---|
| Thrombin production (TG) peak | Baseline to 24 hours |
| Activated partial thromboplastin time | Baseline to 24 hours |
Countries
China
Outcome results
None listed