Psoriatic Arthritis,PsA
Conditions
Interventions
experimental group:Oral administration of WXSH0408 capsule
control group:Oral administration of the placebo
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult male/female subjects between 18 and 45 years of age (inclusive) at the time of signing the informed consent form (ICF); 2. Must have a body mass index (BMI) between 19 and 25 kg/m2 (inclusive); 3. According to the medical history,vital signs,physical examination,12-lead electrocardiogram(ECG),virus antibody testing(serology) and laboratory examination, no evidence of active or chronic disease; 4. Subjects must understand and voluntarily sign an ICF prior to any study-related procedures being conducted; 5. Female subjects who are able to become pregnant have a negative pregnancy test at screening.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating female subjects who do not comply with the acceptable effective forms of contraception or are during window period at screening; 2. History of clinically significant cardiovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, skin, infectious, malignant, hematological disease, 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 to Treponema pallidum or human immunodeficiency virus(HIV) antibodies at screening; 4. History of diarrhea within 3 months before dosing; 5. History of drug abuse or a positive drug screen reflecting consumption of illicit drugs; 6. Exposure to an investigational drug(new chemical entity) within 3 months prior to dosing; 7. History of any definite allergy; 8. Donation or loss of greater than 400ml of blood within the prior 2 months; 9. Have any significant acute disease during the preceding 4 weeks before screening; 10. Regular alcohol consumption =14 units per week(1 unit = 285mL of beer, or 25 mL of spirit, or 100 mL of wine); 11. Smoked(>=5 cigarettes one day) or used any nicotine replacement products within 2 weeks before dosing; 12. A confirmed positive alcohol breath test at screening,or the subject is unwilling to withdrawl alcohol; 13. Positive and clinically significant laboratory tests at screening, judged by the investigator; 14. Subjects who have serious cardiovascular disease(CVD) or have a high risk of CVD or ECG abnormal of clinically significance; 15. Has received a live (whether or not attenuated) vaccine within 12 weeks before dosing; 16. History of severe respiratory or thoracic diseases or thoracic X-ray abnormal of clinical significance which makes the subject not suitable for the study; 17. Has prior major surgery or trauma or bone fracture within 6 months prior to screening,or pretended to accept the surgery during the study; 18. Smokes cigarettes, drinks alcohol or anything caffeined or xanthine related (such as coffee,strong tea and chocolate), or exercises vigorously, or has other factors the effects absorption,distribution, metabolism and excretion in the preceding 7 days since dosing; 19. Has infections or impaired immune diseases or active chronic infections; 20. Has a history of recurrent headache,migraine,tension headache,dizziness and vertigo; 21. History of recurrent musculoskeletal disease, or is suffering from arthralgia or backache; 22. Any other risk that would be brought to the subject by attending the study or any situation that would interrupt the study, judged by the investigator.
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 ContactChen Yu
Shanghai Xuhui Central Hospital
Outcome results
None listed