atopic dermatitis
Conditions
Interventions
75mg group, 150mg group, 300mg group, 450mg group, 600mg groups:QX005N injection vs.placebo
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. When signing the informed consent form, healthy adults aged 18-45 (including both ends) years old; 2. The weight of male subjects are between 50 kg and 100kg, and the weight of female subjects are between 45 kg and 100kg (including both ends); Body mass index (BMI = weight/height square (kg/m2)) are between 18 and 26 kg/m2 (including both ends). 3. After comprehensive examination including general physical examination and laboratory examination (blood routine test, blood biochemistry test, urine routine test, blood coagulation test, thyroid function test and humoral immunity test), 12 lead ECG, abdominal ultrasound and chest X-ray examination showed no abnormality or slight abnormality but no clinical significance; 4. Agree to take effective contraceptive measures voluntarily during the trial and within 6 months after the end of the trial. See Appendix 3 for specific contraceptive measures; 5. Able to read and fully understand the perspectivenaturemethod and possible adverse reactions of study and willing to sign the informed consent form (ICF) 6. Those who can complete the test according to the clinical study protocal.
Exclusion criteria
Exclusion criteria: 1. Abnormal immune system function disease and history before screening 2. Have a history of drug or other allergy and the risk of participating in this study was higher , or may be allergic to the study drug or any component of the study drug according to the judgment of the researcher 3. Those who have a history of drug abuse in the past five years or have used drugs three months before the test; or those who are positive in urine drug abuse after screening 4. These ones with positive HBsAg, HCV antibody, syphilis antibody and HIV antibody. 5. Those with infection (including chronic or local infection) in the past 7 days, those with a history of recurrent infection and underlying diseases prone to infection, disseminated herpes simplex infection or recurrent (> 1 time) or disseminated herpes zoster, and opportunistic infection. 6. Those with a history of active tuberculosis, or those with active or latent tuberculosis infection during screening; 7. Those with blood donation = 400 ml within 4 weeks before screening, or serious hemorrhage and hemorrhage at least equal to 400 ml, or received blood transfusion within 8 weeks. 8. those who plan to receive live (attenuated) vaccine 4 weeks before screening or during the trial. 9. Used any prescription medicine or Chinese herbal medicine within 4 weeks before administration, Or used over-the-counter or dietary supplements (including vitamin and calcium supplements) within 2 weeks. 10. Existing abnormal or disease, and investigators believe it has clinical significance or influences the research, including but not limited to nervous system, cardiovascular system, kidney, liver, gastrointestinal tract (such as dysphagia, gastrointestinal ulcer), respiratory system, blood system, metabolism, ophthalmology(Conjunctivitis, keratitis), gynecology (female subjects), skeletal system diseases or infectious diseases; 11. Those who smoked more than 5 cigarettes per day or used nicotine containing products habitually within 3 months before screening, drinked more than 14 units of alcohol per week within 6 months before screening (1 unit of alcohol = 360 ml of beer or 45 ml of liquor or 150 ml of wine with 40% of alcohol content) or take products containing alcohol 2 days before administration 12. Those who have participated in clinical trials of any drug or medical device within 3 months before screening; 13. Female subjects with positive pregnancy test or during lactation; 14. In the opinion of the investigator, any other situation that may affect the informed consent of the subjects or the compliance with the test scheme, or the subjects' participation in the test may affect the test results or their own safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indices;Pharmacokinetic indices;Immunogenicity index; | — |
Countries
China
Contacts
Public ContactChen Rui, Jin Hongzhong
Peking Union Medical College Hospital
Outcome results
None listed