Thrombotic disease
Conditions
Interventions
1:5 mg ZIFA01/Placebo /rivaroxaban
2:10 mg ZIFA01/Placebo /20mg rivaroxaban
3:15 mg ZIFA01/Placebo /20mg rivaroxaban
4:7.5 mg ZIFA01/Placebo
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Aged between 18 and 45 years old; (2) The body mass index (BMI) is between 19.0 and 26.0 kg/m2 (including 19.0 and 26.0 kg/m2), and the male subject weight >=50 kg and the female subject weight >=45 kg; (3) The investigator judges that the subjects' overall health is good ,basing on the subject's medical history, vital signs, physical examination, laboratory tests (including blood routine, urine routine, blood biochemistry, coagulation, feces routine + occult blood), 12-lead ECG and chest X- Ray et al.; (4) To be able to communicate normally with medical staff and comply with relevant hospital management regulations; (5) Subjects voluntarily sign informed consent and are willing and able to comply with all test requirements.
Exclusion criteria
Exclusion criteria: (1) those who are known or suspected to be allergic to the test drug or any of the components; (2) A person with a history of disease such as cardiovascular, liver, kidney, digestive tract, mental nerve, coagulopathy diseases(such as hemophilia), or with an increased risk of bleeding (such as hemorrhagic stroke, nosebleed, Patients with acute gastroenteritis, gastrointestinal ulcers, hemorrhoids, etc.; (3) Had a large-scale operation within 6 months, or have a surgical plan within one month after the end of the trial; (4) physical examination, vital signs, blood routine, blood biochemistry, urine routine, stool routine + occult blood, coagulation five, 12-lead ECG or chest X-ray and other laboratory tests are abnormal and clinically significant; (5) Hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive; (6) Those who have long-term drinking, smoking and other bad habits. Specifically: drinking more than 14 units (male) and 7 units (female) per week (1 unit = 360 mL beer, or 150 mL of wine, or 45 mL of white wine); smoking more than 5 cigarettes per day or ingesting the same amount of nicotine or Nicotine substitute; (7) habitual consumption of grapefruit juice, tea, coffee and / or caffeinated beverages (more than 8 cups per day, 350ml / cup), and can not be withdrawn during the trial; (8) Those who use any prescription or over-the-counter drug within 2 weeks before the first dose [allow occasional use of topical medications (nasal drops and ointments); any drug that inhibits or induces hepatic enzymes within 4 weeks prior to the first dose. (eg, inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - ketoconazole, itraconazole, cimetidine, diltiazem, macrolides , nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); (9) Those who have lost more than 400 mL (including 400 mL) due to blood donation, surgery or other factors within 3 months before screening; (10) Those who have participated in any drug clinical trial within 3 months before screening; (11) Female or male subjects with family planning within 6 months; (12) women of childbearing age who are pregnant, lactating or women who have a positive pregnancy test during the test; (13) Males with fertility (except for bilateral vasectomy and vasectomy), who do not agree to use condoms or other methods throughout the study to ensure effective sexual contraception; (14) Women with fertility (except for at least one year of menopause, or surgical sterilization, such as bilateral tubal ligation and fallopian tube recanalization, bilateral ovariectomy or hysterectomy),who do not agree to use during the entire study period Effective contraceptives (eg, intrauterine hormone devices, barrier-based contraceptive methods, partner removal of the vas deferens or abstinence); (15) In the first year prior to screening, there is a history of drug abuse and drug use, or a positive screening for urinary drug abuse; (16) Those who have special dietary requirements and fail to follow a unified diet (such as intolerance to standard meals, lactose intolerance, etc.) or who have difficulty swallowing; (17) poor peripheral venous access conditions; (18) Other investigators believe that it is not suitable for the subject to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE;SAE;AESI;Vital signs;Routine blood test;routine urine test;Blood biochemistry;routine feces test;Coagulation function;ECG;physical examination;Pregnancy examination;Concentration of ZIFA01 in plasma; | — |
Secondary
| Measure | Time frame |
|---|---|
| PT;APTT;Anti-factor_a Activity; | — |
Countries
China
Contacts
Public ContactCui Yimin
Peking University First Hospital
Outcome results
None listed