Thrombotic disease
Conditions
Interventions
single dose escalation 100mg group:CRB4101 tablets 50mg, qd
single dose escalation 200mg group:CRB4101 tablets 200mg, qd
single dose escalation 400mg group :CRB4101 tablets 400mg, qd
single dose escalation 800mg group :CRB4101 tablets 800mg, qd
single dose escalation 1200mg group :CRB4101 tablets 1200mg, qd
single dose escalation 1600mg group :CRB4101 tablets 1600mg, qd
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female participants aged between 18 and 50 years (including 18 and 50 years) (the ratio of male/female participants to all is required to be no less than 1/3 in the groups with the dose of 200mg, 400mg and 800mg); 2. Male weight in the range of 50 kg (inclusive) to 90kg, female weight in the range of 45 kg (inclusive) to 90 kg, body mass index (BMI= weight/height square (kg/?)): 19.0 <= BMI < 28.0; 3. Participant who is able to communicate well with the investigator and is willing and able to comply with all planned visits, laboratory examinations, and other study procedures; 4. Have fully understood this study, voluntarily participated in the experiment, and have signed written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant, lactating women, or female participants of childbearing potential who have not used contraception for at least 30 days before drug administration; Male participants who are unwilling to use contraception (or could not guarantee not to donate sperm) and female participants of childbearing potential who are unwilling to use contraception during enrollment in the trial and for 90 days after dosing; 2. Suspected or definitely confirmed (inquiry) allergy to the study drug or any component in the study drug, or allergic constitution; 3. Participants with diseases or previous diseases (including but not limited to cardiac/cardio-cerebrovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatological, malignant, hematological, immune, infectious, neurological or psychiatric diseases), surgical history or any other conditions judged by the investigator to affect the absorption, distribution, metabolism and excretion of drugs or to reduce compliance; 4. Have a personal or family history of bleeding diseases or coagulopathy, or have long-term or unexplained abnormal bleeding, such as frequent epistaxis (nosebleeds), gum bleeding, or have a high risk of bleeding such as hemorrhoids, gastrointestinal ulcers, or often have unexplained bruises/ecchymosis; participants with definite history of hemoptysis, hematemesis, melena or hematuria; Or women who are expected to be menstruating at the time of administration; 5. History of cerebral hemorrhage (including congenital cerebral vascular malformations such as cerebral arteriovenous malformations or cavernous hemangiomas), stroke, and cerebrovascular accident (CVA); 6. Have had risk factors for torsade de pointes, or have had a first-degree relative (i.e., biological parent, sibling, or child) family history of short QT syndrome, long QT syndrome, unexplained sudden death, drowning, or sudden infant death in young adulthood (less than or equal to 40 years of age); 7. Abnormal and clinically significant hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia as judged by the investigator; 8. Participants received anticoagulant or antiplatelet therapy within 1 month before screening; Or with adverse reactions of anticoagulant or antiplatelet drugs; 9. Participants with severe head trauma or major head surgery within 2 years before screening; 10. Underwent major surgery within 3 months before screening or any surgery within 1 month before screening or plan to undergo surgery within 2 weeks after the end of the study; 11. Individuals who has donated blood within 1 month prior to screening, or donated =400 mL of blood within 3 months prior to screening, or received blood or blood component transfusion within 8 weeks prior to screening and before dosing; 12. Taking any prescription drugs, over-the-counter drugs or herbal medicines within 2 weeks before taking the study drug, or within 5 half-lives of the drug at the time of screening; 13. Regular alcohol use in the 3 months before screening (14 units per week: 1 unit = 285 mL of beer; Or liquor 25 mL; Or wine 125 mL), or with abnormal results of alcohol breath test before enrollment; 14. Smoking (>=5 cigarettes per day) or using smoking cessation products or nicotine-containing products within 2 weeks before taking the study drug; Or unable to stop using any tobacco-based products after enrollment throughout the trial; 15. Participants with glucose intolerance or rare genetic diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of CRB4101 in plasma;Concentration of CRB4101 in urine;Concentration of CRB4101 in feces;activated partial thromboplastin;coagulation factor XI; | — |
Contacts
Public ContactHaiyan Li
Peking University Third Hospital
Outcome results
None listed