Inflammatory bowel disease
Conditions
Interventions
experimental group:Oral administration of WXSH0081 tablet
Control group:Placebo
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged 18-45 (including the upper and lower limits) at the time of signing the informed consent, regardless of gender; 2. Subjects with body mass index (BMI) of 19-26 kg / m2 (including upper and lower limits); 3. After detailed medical history, comprehensive physical examination (vital signs and physical examination), laboratory examination (blood routine examination, blood biochemical examination, urine routine examination, coagulation function, etc.), 12 lead ECG, serum aetiology and other examinations, there is no evidence that the subject has active or chronic diseases, or comprehensive physical examination, laboratory examination, 12 lead ECG and serum aetiology were abnormal but without clinical significance; 4. Subjects who have fully understood the study, participated in the study voluntarily and signed the ICF; 5. The pregnancy test results of female subjects must be negative. The subjects have no family planning from 2 months before screening to 3 months after the last administration, and the subjects and partners of childbearing age must use appropriate contraceptive methods.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating female;subjects who do not comply with the acceptable effective forms of contraception or did not adopt appropriate contraceptive methods within 2 months before screening; 2. History or current diseases of clinical significance (including more than cardiovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, skin, infectious, malignant, hematological, neurological or psychiatric disorder(for example, depression)); 3. Known to be a carrier of the hepatitis B surface antigen(HBsAg) or hepatitis C antibody(HCV Ab),or have a positive result to the test of Treponema pallidum or human immunodeficiency virus(HIV) antibodies at screening; 4. The white blood cell count or/and lymphocyte count at the time of screening was lower than the lower limit of normal value or higher than the upper limit of normal value, and was judged as abnormal with clinical significance by the investigator; 5. Subjects with major cardiovascular diseases (for example,congestive heart failure, unstable angina, atrial fibrillation, arrhythmia, etc.);or abnormal ECG with clinical significance [ ECG shows QTc interval >=450 msec (calculated by Fridericia formula), or PR interval > 200 msec];Right bundle branch block + left anterior branch block or complete left bundle branch block;Subjects with congenital long QT syndrome;Subjects with a history of ventricular tachyarrhythmia or at screening;Bradycardia (=140 mmHg and/or diastolic blood pressure >=90mmHg) or abnormally decreased blood pressure (systolic blood pressure = 14 units per week(1 unit = 285mL of beer, or 25 mL of spirits, or 100 mL of wine); 19. Subjects who smoked(>=5 cigarettes one day) or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory tests;routine 12-leads electrocardiogram;vital signs;physical examination;Adverse events and severe adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactAixin Shi
Beijing hospital
Outcome results
None listed