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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A single lowest dose of treatment group | Experimental |
| |
| A single low dose of treatment group | Experimental |
| |
| A single low-intermediate dose of treatment group | Experimental |
| |
| A single intermediate dose of treatment group | Experimental |
| |
| A single high dose of treatment group | Experimental |
| |
| A single highest dose of treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STSP-0601 for Injection | Drug | Subjects will receive one single lowest dose of STSP-0601 for Injection following protocol requirements |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Activated partial thromboplastin time | Baseline to 24 hours | |
| Thrombin production (TG) peak | Baseline to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lei Zhang | Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | Tianjin | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36796484 | Derived | Liu W, Xue F, Fu R, Ding B, Li M, Sun T, Chen Y, Liu X, Ju M, Dai X, Wu Q, Zhou Z, Yu J, Wang X, Zhu Q, Zhou H, Yang R, Zhang L. Preclinical studies of a factor X activator and a phase 1 trial for hemophilia patients with inhibitors. J Thromb Haemost. 2023 Jun;21(6):1453-1465. doi: 10.1016/j.jtha.2023.01.040. Epub 2023 Feb 14. |
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| STSP-0601 for Injection | Drug | Subjects will receive one single low dose of STSP-0601 for Injection following protocol requirements |
|
| STSP-0601 for Injection | Drug | Subjects will receive one single low-intermediate dose of STSP-0601 for Injection following protocol requirements |
|
| STSP-0601 for Injection | Drug | Subjects will receive one single intermediate dose of STSP-0601 for Injection following protocol requirements |
|
| STSP-0601 for Injection | Drug | Subjects will receive one single high dose of STSP-0601 for Injection following protocol requirements |
|
| STSP-0601 for Injection | Drug | Subjects will receive one single highest dose of STSP-0601 for Injection following protocol requirements |
|
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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