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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Subjects will receive one single lowest dose of STSP-0601 for Injection following protocol requirements
Subjects will receive one single low dose of STSP-0601 for Injection following protocol requirements
Subjects will receive one single low-intermediate dose of STSP-0601 for Injection following protocol requirements
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China
Number of subjects of adverse events
Time frame: Baseline to 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
Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings
Time frame: Baseline,1 hour,4 hour,48 hour,Day 8
Activated partial thromboplastin time
Time frame: Baseline to 24 hours
Thrombin production (TG) peak
Time frame: Baseline to 24 hours
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Subjects will receive one single intermediate dose of STSP-0601 for Injection following protocol requirements
Subjects will receive one single high dose of STSP-0601 for Injection following protocol requirements
Subjects will receive one single highest dose of STSP-0601 for Injection following protocol requirements