Atopic dermatitis
Conditions
Interventions
Group 1:Subcutaneous injection of QX005N
Group 2:Intravenous injection of QX005N
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adults aged 18-50 (including both ends) when signing the informed consent form; 2. The weight of male subjects is >= 50.0 kg, and the weight of female subjects is >= 45.0 kg, and both are <= 100.0 kg; the body mass index (BMI = weight/height square (kg/m2)) is within the range of 18.0-28.0 kg/m2 (both values ??included); 3. After a comprehensive examination, including vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, abdominal color Doppler ultrasound and frontal chest X-ray, the examination is normal or abnormal but has no clinical significance; 4. Agree to have no birth plan and voluntarily take effective contraceptive measures during the trial and within 6 months after the trial; 5. The subject fully understands the purpose, nature, method and possible adverse reactions of the test, volunteers as a subject, and signs an informed consent; 6. Those who can complete the test according to the requirements of the plan.
Exclusion criteria
Exclusion criteria: 1. Those who have previously received drugs with the same target (IL-4Ra); 2. Those who are allergic to two or more drugs or food, or who are judged by the investigator to be allergic to the study drug or any ingredient in the study drug; 3. Those who had a history of drug abuse within five years before the screening or those who used drugs 3 months before the test; or those who were positive in urine drug abuse screening; 4. Qualitative hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), hepatitis C virus core antigen (HCV-cAg), human immunodeficiency virus (HIV) antigen antibody joint detection, Treponema pallidum-specific antibody assay (TP-ELISA) has one or more positive cases; 5. Patients with infection (including chronic or local infection) within 7 days prior to screening, with a history of repeated infection and underlying diseases prone to infection, with a history of disseminated herpes simplex infection or recurrent (> 1 time) or disseminated herpes zoster, with a history of opportunistic infection; 6. Those with a history of active tuberculosis, or those with active or latent tuberculosis infection during screening; 7. Diseases or abnormalities of the nervous system, cardiovascular system, kidney, liver, gastrointestinal tract, respiratory system, blood system, metabolism, ophthalmology (conjunctivitis, keratitis), gynecology (female subjects only), skeletal system, or infectious diseases deemed by the investigator to be clinically significant or affecting the study; 8. Blood donation >= 400 mL, or blood loss >= 400 mL within 4 weeks before screening, or who have received blood transfusion within 8 weeks before screening; 9. Those who plan to receive live (attenuated) vaccines within 4 weeks before screening or plan to receive live (attenuated) vaccines during the trial; 10. Have used any prescription drugs, Chinese herbal medicines within 4 weeks before screening, or used non-prescription or dietary supplements (including vitamins, calcium supplements, etc.) within 2 weeks before screening; 11. The average daily smoking volume was more than 5 or habitually used nicotine-containing products within 3 months before screening; 12. Those who consumed an average of more than 14 units of alcohol per week in the six months prior to screening (1 unit of alcohol = 360 mL beer or 45 mL 40% spirits or 150 mL wine) or had consumed alcoholic products in the two days prior to administration; 13. Those who have participated in clinical trials of any drug or medical device within 3 months or 5 half-lives (whichever is longer) before screening; 14. Female subjects who have a positive pregnancy test or are breastfeeding; 15. The investigator believes that any other situation that may affect the subject's informed consent or compliance with the trial protocol, or the subject's participation in the trial may affect the trial results or their own safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmaco kinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;immunogenicity; | — |
Countries
China
Contacts
Public ContactGuiling Chen
Jiangsu Qyuns Therapeutics Co.,Ltd.
Outcome results
None listed