Prevention or treatment of arterial and venous thrombosis
Conditions
Interventions
Group 1-15mg:SRSD107 15 mg (n=6) or matching placebo (n=2), single subcutaneous injection.
Group 2-45mg:SRSD107 45 mg (n=6) or matching placebo (n=2), single subcutaneous injection.
Group 3-120mg:SRSD107 120 mg (n=6) or matching placebo (n=2), single subcutaneous injection.
Group 4-240mg:SRSD107 240 mg (n=6) or matching placebo (n=2), single subcutaneous injection.
Group 5-450mg:SRSD107 450 mg (n=6) or matching placebo (n=2), single subcutaneous injection.
Group 6-600mg:SRSD107 15 mg (n=6) or matching placebo (n=2), single subcutaneous injection.
Sponsors
Beijing Tiantan Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Males or females, of any race, between 18 and 65 years of age, inclusive. 2. Body mass index between 18.0 and 32.0 kg/m^2, inclusive. 3. In good health, determined by no clinically significant findings from medical history, physical examination, clinical laboratory evaluations (unconjugated hyperbilirubinemia, providing it is consistent with Gilbert’s syndrome is acceptable), 12 lead ECG, and vital signs measurements, at screening and check in, as assessed by the investigator (or designee). 4. Activated partial thromboplastin time and prothrombin time within the normal reference range. 5. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception. 6. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Exclusion criteria
Exclusion criteria: Medical Conditions 1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). 2. History or evidence of any abnormal bleeding or coagulation disorder; or evidence of coagulopathy, prolonged or unexplained, clinically significant bleeding, or frequent unexplained bruising or thrombus formation; or a history of spontaneous bleeding. 3. Evidence of an active or suspected cancer, or a history of malignancy, within 5 years prior to screening. Nonmelanoma skin cancer, curatively treated localized prostate cancer, or other carcinoma in situ are not exclusionary, providing that they did not require systemic therapy and are considered cured. 4. Acute of febrile illness within 7 days prior to dose administration or evidence of active infection. 5. Any major surgery within 3 months prior to screening or plan to have any surgery during the study. 6. History of clinically significant hypersensitivity, intolerance, or allergy to any drug compound, oligonucleotide, GalNAc, food, or other substance, as determined by the investigator (or designee). 7. Systolic blood pressure >140 mmHg or 90 mmHg or 450 ms confirmed by repeat measurement. 9. Platelet count or hemoglobin level below the lower limit of normal. 10. Alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, alkaline phosphatase, or total bilirubin >1.5 × the upper limit of normal. Elevated total bilirubin is acceptable if resulting from unconjugated hyperbilirubinaemia and is consistent with Gilbert's syndrome. 11. Estimated glomerular filtration rate 80 mL or menstrual periods were >7 days. Prior/Concomitant Therapy 15. Use or intend to use any of the following, as determined by the investigator (or designee): a. prescription medications/products or herbal products within 14 days or 5 terminal elimination half lives, whichever is longer, prior to dose administration in this study b. over the counter medications/products within 7 days prior to dose administration in this study Recommended doses of vitamin and mineral supplements, over the counter analgesics (eg, paracetamol or ibuprofen for the treatment of acute conditions [eg, headache]), prescription oral, implantable, transdermal, injectable, or intrauterine contraceptives, and other products that have been approved by the investigator will not be exclusionary. Hormone replacement therapy will not be exclusionary, providing that the regimen has been stable for at least 2 months prior to screening and will not be changed during the study. 16. Immunization with any live vaccine within 6 weeks prior to screening, or expected to require immunization with any live vaccine during the study. Prior/Concurrent Clinical Study Ex
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endppoint-Incidence and severity of adverse events;Safety endpoint-Lab test parameters;Safety endpoint-ECG parameters;Safety endpoint-vital signs;Safety endpoint - Physical examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic biomarker-FXI antigen level;PK index;Drug-resistant antibody;Pharmacodynamic biomarker- FXI clotting activit;Pharmacodynamic biomarker- Activated partial thromboplastin time;Pharmacodynamic biomarker- Prothrombin time; | — |
Countries
China
Contacts
Public ContactYongjun Wang; Shuya Li
Beijing Tiantan Hospital Affiliated to Capital Medical University
Outcome results
None listed