Prevention and treatment of thrombotic diseases
Conditions
Interventions
SAD 300mg:SAL0104 capsule 300mg single dose/ placebo
SAD 600mg:SAL0104 capsule 600mg single dose/ placebo
SAD 900mg:SAL0104 capsule 900mg two cycles of single dose/ placebo
SAD 1200mg:SAL0104 capsule 1200mg single dose/ placebo
MAD 300mg:SAL0104 capsule 300mg bid/ placebo
MAD 600mg:SAL0104 capsule 600mg bid/ placebo
MAD 900mg:SAL0104 capsule 900mg bid/ placebo
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Fully understood and voluntarily signed the informed consent form for this study, and can comply with the requirements and restrictions listed in the informed consent form. 2.Male or female subjects aged 18-45 years old(including 18 and 45) (except those unable to avoid menstruation during drug administration) (no less than 1/3 female subjects). 3.Male weight =50kg, female =45kg, BMI between 19.0kg/m^2 and 28.0kg/m^2 (including 19.0kg/m^2 and 28.0kg/m^2; BMI= weight ÷ height^2) at screening. 4.The results of all examinations (including physical examination, vital signs, blood routine, urine routine, blood biochemistry, coagulation function, serum virology, 12-lead electrocardiogram, chest radiograph, abdominal color ultrasound, etc.) were normal or slightly abnormal but not clinically significant. 5.The subject or his/her partner does not plan to be pregnant during the study or within 3 months after the final dose of the study. Voluntarily takes effective contraceptive measures (no use of acyeterion during the study) to avoid becoming pregnant, and do not donate sperm or eggs for reproductive or assisted reproductive purposes.
Exclusion criteria
Exclusion criteria: 1.Women in pregnancy or lactation, or women of childbearing age tested positive for pregnancy. 2.The presence of any medical conditions (e.g., acute gastritis, digestive tract ulcers, purpura, lupus erythematosus, etc.) or medical history (e.g., history of intracranial hemorrhage, history of intraocular hemorrhage, history of hemophilia, history of von Willebrand disease, etc.) that could alter or increase the tendency to bleed 3.History of clinically significant acute drug or food allergic reactions, or allergic conditions (such as allergy to two or more drugs, foods or pollens), or history of allergic diseases (such as asthma, urticaria, eczema dermatitis, etc.) within 2 weeks before screening. Or determineed by the investigator, it is possible or clear to have allergic reaction, hypersensitivity reaction or clinically significant reaction to the study drug (SAL0104 capsule or control drug) and any excipients. 4.Previous or current thrombotic disease requiring anticoagulant or antiplatelet therapy. 5.Have taken any food or drink containing dragon fruit, mango, grapefruit, papaya, pomegranate, star fruit or other ingredients that affect drug absorption, distribution, metabolism, or excretion within 48 hours before first dose. 6.Any positive result of HBsAg, HCVAb, HIV antibody or syphilis. 7.Any of the following foods, drugs, or treatments were used before first dose: 1)UGT1A1 inhibitor or inducer has been used within 2 weeks before first dose or for 5 half-lives (whichever is longer). 2)Any prescription drugs or Chinese herbs were used within 4 weeks before first dose. 3)Any OCT drugs or food supplements were taken (including vitamins, health foods, etc.) within 2 weeks before first dose. 4)Any food or drink containing alcohol or caffeine were consumed within 72 hours before first dose. 8.Drug or substance abuse, alcohol or tobacco abuse: 1)History of drug abuse or substance abuse, or a positive result of substance abuse at screening. 2)Average weekly alcohol consumption within 3 months before screening is more than 14 units (1 unit ˜17.7mL ethanol, i.e. 1 unit ˜ 360mL beer with 5% alcohol content, or 45mL liquor with 40% alcohol content, or 150 ml wine with 12% alcohol content), or positive alcohol breath test results at screening, or unable to completely stop consuming any food or drink containing alcohol during the study. 3)Smoking more than 5 cigarettes per day within 3 months before screening, or unable to completely stop using any tobacco products during the study. 4)Average daily consumption of more than 500mg of caffeine (5 cups of tea or coffee, or 8 cans of soda or other caffeinated products) within 3 months before screening. 9.Blood donation (including component donation) or blood loss of =400mL within 3 months before screening. Blood donation (including component donation) or blood loss of =200mL or blood transfusion received within 1 month before screening. Have plan to donate blood or blood composition during the study, or within 1 month after the study. 10.Have difficulty in blood collection or inability to tolerate multiple venipunctures. History of needle fainting or blood fainting judged by the researcher as clinically significant. 11.Vaccination with live vaccine, live attenuated vaccine or vaccine with any live virus component has been or is scheduled to be administered within 3 months before screening, during the study or within 1 month after the study. 12.Have experienced severe trauma or major
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters;Pharmacodynamic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory examination;AE/SAE;Vital signs;Physical examination;ECG; | — |
Countries
China
Contacts
Public ContactHaiyan Li, Dongyang Liu
Peking University Third Hospital
Outcome results
None listed