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

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.

Official Title
-----------------
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

Conditions
-----------------
Hemophilia

Intervention / 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


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A single lowest dose of treatment group<br> | Drug: STSP-0601 for Injection<br>* Subjects will receive one single lowest dose of STSP-0601 for Injection following protocol requirements<br>|
| Experimental: A single low dose of treatment group<br> | Drug: STSP-0601 for Injection<br>* Subjects will receive one single low dose of STSP-0601 for Injection following protocol requirements<br>|
| Experimental: A single intermediate dose of treatment group<br> | Drug: STSP-0601 for Injection<br>* Subjects will receive one single intermediate dose of STSP-0601 for Injection following protocol requirements<br>|
| Experimental: A single high dose of treatment group<br> | Drug: STSP-0601 for Injection<br>* Subjects will receive one single high dose of STSP-0601 for Injection following protocol requirements<br>|
| Experimental: A single highest dose of treatment group<br> | Drug: STSP-0601 for Injection<br>* Subjects will receive one single highest dose of STSP-0601 for Injection following protocol requirements<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects of adverse events |  | Baseline to Day 8 | 
| Number of subjects With Significant Abnormal Physical Examination |  | Baseline to Day 8 | 
| Number of subjects of Significant Abnormal Vital Signs Findings |  | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activated partial thromboplastin time |  | Baseline to 24 hours | 
| Thrombin production (TG) peak |  | Baseline to 24 hours |