Thromboembolic disease
Conditions
Interventions
Control group:placebo
Experimental group:SKB336 injection
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged 18-55 years (including the critical value) when signing the informed consent, regardless of gender; 2. Male subjects should not be less than 50 kg, female subjects should not be less than 45 kg, and the body mass index [BMI=weight (kg)/height2 (m^2)] should be in the range of 19.0-26.0 kg/m^2 (including the critical value); 3. For female subjects, the time of receiving the drug should be expected to be within 1-14 days after the end of the physiological period (at least one urine occult blood test result is negative); 4. The subjects participated voluntarily and signed the informed consent form, were able to communicate well with the researchers and completed the study according to the protocol.
Exclusion criteria
Exclusion criteria: 1. The results of physical examination, vital signs monitoring, electrocardiogram and laboratory examinations (including routine blood, urine routine, blood biochemistry, thyroid function, fecal occult blood, coagulation, etc.) during the screening period, and the investigator judges that the abnormality has clinical significance; 2. Known family history of blood disorders, such as von-Willebrand disease or hemophilia A, B or C, or thrombocytopenia; 3. Known intracranial arteriovenous malformation or hemangioma; 4. Past or existing malignant tumors, gastrointestinal diseases (such as ulcers, history of bleeding), neurological diseases, tuberculosis, bronchiectasis, intracerebral/intracranial/fundus hemorrhage; 5. Those with allergic diseases, severe drug allergy history, known allergy to macromolecular protein preparations or any components in the prescription of SKB336 injection; 6. Thromboembolic events, such as acute coronary syndrome, stroke, myocardial infarction, unstable angina pectoris or coronary artery bypass surgery, have occurred within 12 months before the first administration of the study; 7. Those who have been drinking excessively (more than 8 cups a day, 1 cup = 250 ml) tea, coffee or caffeinated beverages in the past, ingest any food or beverages containing caffeine within 48 hours before the first dose of the study (such as coffee, strong tea, chocolate, etc.); 8. Those who have long-term drinking, smoking and other bad habits. Specifically: drinking more than 14 units (men) and 7 units (women) per week (1 unit = 360 ml of beer, or 150 ml of wine, or 45 ml of liquor); Smoking more than 5 cigarettes per day; those with a positive alcohol breath test during the screening period or those who do not receive smoking or drinking during the study period; 9. Those with a history of drug abuse or drug abuse, and the drug urine screening test is positive during the screening period; 10. During the screening period, those who are positive for any one of the infectious disease screening tests for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody; 11. Those who have suffered severe head trauma within 2 years before the first administration of the study; 12. Those who have undergone major surgery within 12 months before the first administration of the study, or those who plan to undergo major surgery within 6 months after signing the informed consent form after the end of the study; 13. Lactating subjects, as well as male subjects (or their partners) or female subjects who have a reproductive plan within 6 months after signing the informed consent form and are unwilling to take appropriate contraceptive measures; Men plan to donate sperm from the time of signing the informed consent to 6 months after the end of the study; women plan to donate eggs from the time of signing the informed consent to 6 months after the end of the study; 14. Participated in blood donation, blood transfusion or bleeding (any item >= 200 ml) within 3 months before the first administration of the study, or planned to be an organ donor (including blood, bone marrow, blood components) within 6 months after the end of the study after signing the informed consent; 15. Those who have received other clinical trial drugs within 3 months before the first dose of the study; 16. Those who have used any prescription drugs, non-prescription drugs, Chinese herbal medicines, health products (incl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics (PK);immunogenicity; | — |
Countries
China
Contacts
Public ContactCui Yimin
the First Hospital of Peking University
Outcome results
None listed