Immune system diseases
Conditions
Interventions
Sponsors
Deyang People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. The subject fully understands the purpose, nature, process and possible adverse reactions of the trial, voluntarily acts as a subject, and signs the informed consent form before the start of all study procedures; 2. Age 18~45 years old (including the cut-off value); 3. Male weight >= 50.0 kg, female weight >= 45.0 kg; Body mass index (BMI) within the range of 19.0~26.0kg/m^2 (including the cut-off value); 4. Subjects (including male subjects) voluntarily take effective contraceptive measures during the trial and within 3 months after the end of the trial, and have no plans for childbirth, sperm donation and egg donation; 5. Be able to communicate well with the researcher, and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Those with a history of specific allergies (asthma, urticaria, eczema, etc.) or allergies (such as those who are known to be allergic to two or more drugs, foods such as milk and pollen), especially those who are allergic to dexamethasone acetate and its excipients (lactose, corn starch, povidoneK30, magnesium stearate, talcum powder, etc.), adrenal corticosteroids; 2. Patients with abnormal clinical manifestations that need to be excluded in the past or at present, including but not limited to neurological/psychiatric, respiratory system (tuberculosis), cardiovascular and cerebrovascular system (hypertension, thrombosis, myocardial infarction), digestive system (gastric and duodenal ulcer, history of any gastrointestinal disease that affects drug absorption), blood and lymphatic system, liver and kidney function, endocrine system, immune system diseases (fungal, viral infection), abnormal electrolyte metabolism, eye diseases (glaucoma, cataract), diabetes, osteoporosis; 3. Those who have vital signs examination, physical examination, clinical laboratory examination (blood routine, urinalysis, blood biochemistry, coagulation, etc.), chest low-dose CT and 12-lead electrocardiogram at screening, and the results show abnormalities and are clinically significant; 4. Those who have undergone surgery that will affect drug absorption, distribution, metabolism and excretion as judged by the investigator within 3 months before screening, or those who plan to undergo surgery during the study; 5. Those who have been vaccinated within 30 days before screening, or plan to receive any vaccine during the trial or within 48h after the last study drug administration; 6. Those who have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal preparations and prescriptions) or health care products within 2 weeks before screening; 7. Those who have one or more positive tests for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antigen+ antibody or treponema pallidum antibody; 8. Use of any drug that inhibits or induces hepatic metabolism of the drug within 30 days before administration (such as inducers - barbiturates, carbamazepine, phenytoin, rifampicin, glucocorticoids, omeprazole; Inhibitors - SSRIs antidepressants, cimetidine, cyclosporine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines, HIV protease inhibitors, etc.); 9. Those who have participated in other clinical trials and taken investigational drugs within 3 months before screening; 10. Those who have donated blood within 3 months before screening, those who have lost blood by blood donation or other reasons within 6 months or more than 400 mL (except for female menstrual blood loss), or those who plan to donate blood or blood components during the study or within 1 week after the end of the study; 11. Those who drink more than 14 units of alcohol per week (1 unit of alcohol ˜ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) per week within 3 months before screening, or those who cannot abstain from alcohol during the trial; or alcohol breath test results greater than 0.0 mg/100mL; 12. Those who smoke more than 5 cigarettes per day within 3 months before screening, or cannot stop using any tobacco products during the trial; 13. Those who drank excessive amounts of tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL) ev
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2;?z;CL/F;Vd/F;AUC% Extrap;Adverse event; | — |
Countries
China
Contacts
Public ContactGang Mai; Lianlian Fan
Deyang People's Hospital
Outcome results
None listed