Thrombotic disease
Conditions
Interventions
single dose escalation 50mg group:SAL0104 capsule 50mg, qd
single dose escalation 150mg group:SAL0104 capsule 150mg, qd
single dose escalation 400mg group:SAL0104 capsule 400mg, qd
single dose escalation 800mg group:SAL0104 capsule 800mg, qd
single dose escalation 1200mg group:SAL0104 capsule 1200mg, qd
single dose escalation 1600mg group:SAL0104 capsule 1600mg, qd
multiple dose escalation 200mg group:SAL0104 capsule, D1-D2: 200mg, qd
D3-D7: 200mg, bid
D8: 200mg, qd
multiple dose escalation 400mg group:SAL0104 capsule, D1-D2: 400mg, qd
D3-D7: 400mg, bid
D8: 400mg, qd
multiple dose escalation 600mg group:SAL0104 capsule, D1-D2: 600mg, qd
D3-D7: 600mg, bid
D8: 600mg, qd
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Male or female ages 18 to 45 (except menstruating, 5 days before and after menstruating) (no less than 1/3 female subjects in MAD study 400 and 600mg dose groups); 2.At the time of screening, weight of male >=50kg, female >=45kg, BMI is 19.0~28.0kg/m^2 (including 19.0kg/m^2 and 28.0kg/m^2); 3.Willing and able to comply with all protocol requirements, understand the nature of the study, and sign the informed consent as required by the research institution and regulations; 4.The subject will be able to communicate well with the investigator and will be able to complete the study according to the protocol.
Exclusion criteria
Exclusion criteria: 1.Previous or present history of any clinically serious disease, such as malignancy, gastrointestinal and severe liver/kidney/cardiovascular/digestive/nervous system diseases, tuberculosis, mental abnormalities and metabolic abnormalities, or any other disease or physiological condition that could interfere with the results of the study; 2.Patients with abnormal result of any test (including physical examination, vital sign examination, blood routine, urine routine, stool routine, blood biochemistry, coagulation function, 12-lead electrocardiogram, chest X-ray, etc.) judged to be clinically significant and patients with positive occult blood test in stool routine; 3.The investigator determines that the patients have any current or prior 6 months of first administration that can alter or increase the risk of bleeding (e.g., hemorrhoids, acute gastritis, gastrointestinal ulcers, brain/spine/eye surgery, intraocular bleeding, known or suspected esophageal varices, trauma, or bleeding prone organ damage, etc.); 4.Patients with coagulopathy, spontaneous bleeding tendency, intracranial hemorrhage, vascular aneurysm or cerebral vascular malformation; 5.Previous or current thrombotic disease requiring anticoagulant or antiplatelet therapy; 6.Previous or present diseases of the digestive tract such as cholestasis; 7.Patients with gastrointestinal reactions such as vomiting and diarrhea 3 days before the first administration; 8.A history of clinically significant drug allergy or allergic disease (such as asthma, urticaria, eczema dermatitis, etc.), allergic constitution (multiple drugs and/or food allergy), possibly or clearly allergic to the study drug (SAL0104 capsule) and its excipient determined by the investigators; 9.HBsAg, HCV-Ab, HIV-Ab or syphilis test positive; 10.Patients with clinically significant acute infection or complicated severe infection (including but not limited to progressive or active infection) within 2 weeks prior to first administration (e.g., requiring intravenous infusion or oral antibiotics, antifungal or antiviral drugs, etc.); 11.Has smoked more than 5 cigarettes per day or ingested an equivalent amount of nicotine or nicotine replacement, or smoke during the study period, smoke tobacco or used tobacco products within 3 months prior to the first administration or during the study period, including any nicotine containing cessation products such as nicotine capsules, nicotine gum; 12.Chronic excessive consumption of tea (more than 8 cups a day, 1 cup =250mL), coffee or caffeinated beverages, consumption of any caffeinated food or beverage (such as coffee, strong tea, chocolate, etc.) within 48 hours before first administration; 13.Previous heavy drinkers (i.e., drinking more than 28 standard units per week for men, 21 standard units per week for women (1 standard unit contains 14g of alcohol, such as 360mL beer or 45mL of 40% alcohol or 150mL wine), regular drinkers (more than 14 standard units per week) in the 6 months prior to the trial, alcohol drinkers during the study period, or alcohol breath test positive during the screening period; 14.Usage of any prescription drugs, non-prescription drugs, Chinese herbal medicines, health products (including regular vitamin supplements) within 14 days prior to the first administration or 5 half-lives (the longest time counts); 15.A history of drug or substance abuse, or a positive urine test (morphine, methamphetamine, ketamine, dimethylene dioxyamphetamine,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of SAL0104 in plasma;Concentration of SAL0104-0419 in plasma;Concentration of SAL0104 in urine;Concentration of SAL0104-0419 in urine;Concentration of SAL0104 in feces;Concentration of SAL0104-0419 in feces;activated partial thromboplastin;coagulation factor XI; | — |
Countries
China
Contacts
Public ContactLi Haiyan, Liu Dongyang
Peking University Third Hospital
Outcome results
None listed