Adults with Severe, poorly controlled asthma
Conditions
Interventions
QX008N:QX008N injection
Placebo:Placebo
Sponsors
Zhongshan Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adults aged 18 to 45 (inclusive) when signing the ICFs; 2. Male subjects weigh at least 50 kg and no more than 100 kg inclusive, female subjects weigh at least 45 kg and no more than 100 kg inclusive; Have a body mass index between 18 and 26 kg/m2 inclusive [BMI=weight/height squared (kg/m2)]; 3. Subjects receive a comprehensive examination including vital signs in the supine position, general physical examination, laboratory examination, 12-lead electrocardiogram, and abdominal color ultrasound examination, which is normal or abnormal but have no clinical significance; 4. Subjects agree to have no reproductive plan and voluntarily take effective contraceptive measures during the trial and within 6 months after the trial (see Appendix 3 for specific contraceptive measures); 5. The subjects fully understand the purpose, nature, methods, and possible adverse reactions of the trial, voluntarily become subjects, and sign the ICFs; 6. Subjects can complete the trial as required in the protocol.
Exclusion criteria
Exclusion criteria: 1. Prior receipt of anti-TSLP drugs; 2. Subjects with known immune diseases or a history of disease during the screening period; 3. History of drugs or other allergies and the investigator considers that the risk of subjects participating in this study is higher, or subjects may be allergic to the study drug or any ingredient in the study drug; 4. Subjects who had a history of drug abuse within 5 years before screening or had used drugs within 3 months prior to the trial or had a positive test for drug abuse in the urine; 5. Subjects who had positive results for hepatitis B surface antigen in Hepatitis B serologic test, or meet the following three conditions at the same time: anti-HBc positive, anti-HBs negative and HBV DNA results exceeding the normal range; Subjects who had positive results for hepatitis C antibody, Treponema pallidum antibody, or HIV antigen/ antibody test; 6. Subjects with infection within 7 days before screening (including chronic or local infection); history of recurrent infection (>=3 times/year) and underlying diseases that is prone to infection; history of disseminated herpes simplex infection or recurrent (>1 time) or disseminated herpes zoster (HZ), and history of opportunistic infection; 7. Subjects with a history of active tuberculosis, or subjects with active or latent tuberculosis infection at screening; 8. Subjects who have the following diseases within 6 months before screening, including but not limited to diseases of nervous system, cardiovascular system, respiratory system, blood system, endocrine system, urinary system, digestive system, skeletal system, metabolism, psychiatry, infection, ophthalmology, gynecological (female subjects) and other diseases. 9. Subjects who donated blood >= 400 ml within 4 weeks before screening, or had blood loss at least 400 ml, or had received blood transfusion within 8 weeks before screening; 10. Subjects who plan to receive live (attenuated) vaccine within 4 weeks before screening or during the trial; 11. Subjects who have used any prescription drugs, Chinese herbal medicines within 4 weeks before screening, or over-the-counter or dietary supplements (including vitamins, calcium supplements, etc.) within 2 weeks before screening; 12. Subjects who smoked more than 5 cigarettes per day or habitually used nicotine-containing products within 3 months before screening; 13. Subjects who had consumed more than 14 units of alcohol per week within 6 months before screening (1 unit alcohol = 360 ml beer or 45 ml liquor with 40% alcohol or 150 ml wine) or had consumed alcoholic products within 2 days before administration; 14. Subjects who have participated in clinical study of any drug or medical device within 3 months or five half-lives (whichever is longer) before screening; 15. Female subjects whose blood HCG>=5 mIU/mL or who are breastfeeding; 16. Any other circumstances as judged by the investigator that may affect the subjects in providing ICFs or following the study protocol or taking participation in the trial that may affect the results or the subjects safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Tolerance;Pharmacokinetic;Immunogenicity; | — |
Countries
China
Contacts
Public ContactLi Xuening
Zhongshan Hospital of Fudan University
Outcome results
None listed