Adults with Severe, poorly controlled asthma
Conditions
Interventions
Group 2:Subcutaneous injection QX008N 560mg
Group 3:Intravenous injection QX008N 560mg
Group 1:Subcutaneous injection QX008N 280mg
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Subjects who meet all the following inclusion criteria can be included: 1.Healthy adults aged 18 to 50 (inclusive) when signing the ICFs. 2.Male subjects weigh at least 50.0 kg and no more than100.0 kg (inclusive), and female subjects weigh at least 45.0 kg and no more than 100.0 kg (inclusive). Have a body mass index (BMI = weight/height square (kg/m2)) between 18.0-28.0 kg/m2 (inclusive). 3.Subjects whose results are normal or abnormal but not clinically significant after a thorough examination including vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, abdominal ultrasound and orthopantomogram. 4.Subjects who agree to have no childbearing plans and voluntarily use effective contraception during the trial and for 6 months after the trial ends. 5.Subjects fully understand the study objective, nature, methods and possible adverse reactions, voluntarily become subjects, and sign the ICFs. 6.Subjects can complete the trial as required in the protocol.
Exclusion criteria
Exclusion criteria: Subjects who meet one of the following exclusion criteria should be excluded: 1. Prior receipt of the same target (TSLP) drugs. 2. Subjects with a known history of drug or other allergies (two or more), or subjects in the opinion of the investigator, are at higher risk of participating in this study or may be allergic to the study drug or any component of the study drug. 3. 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. 4. Subjects who had one or more positive results for hepatitis B surface antigen, hepatitis C virus antibody, hepatitis C virus core antigen, human immunodeficiency virus antigen-antibody combination test, and syphilis spirochete specific antibody assay at screening. 5. Subjects who had an infection (including chronic or local infection) within 7 days before screening or had a history of Infection-prone underlying diseases or had a history of disseminated herpes simplex infection or recurrent (>1 time) or disseminated herpes zoster (HZ) or had a history of opportunistic infection. 6. Subjects with a history of active tuberculosis, or subjects with active or latent tuberculosis infection at screening. 7. Subjects with known diseases within 6 months prior to screening that the investigator believes are clinically significant or influence the study, including but not limited to neurological, cardiovascular, respiratory, hematological, endocrine, urinary, digestive, skeletal, metabolic, psychiatric, infectious, ophthalmic, and gynecological (for female subjects) diseases. 8. Subjects who donated blood = 400 ml within 4 weeks before the screening, or had blood loss = 400 ml, or had received a blood transfusion within 8 weeks before screening. 9. Subjects who plan to receive the live (attenuated) vaccines within 4 weeks before screening or during the trial. 10. Subjects who have used any prescription drugs, Chinese herbal medicines within 4 weeks before the screening, or over-the-counter or dietary supplements (including vitamins, calcium supplements, etc.) within 2 weeks before screening. 11. Subjects who smoked more than 5 cigarettes per day or habitually used nicotine-containing products within 3 months before screening. 12. 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. 13. Subjects who have participated in a clinical study of any drug or medical device within 3 months or five half-lives (whichever is longer) of the drug before the screening. 14. Pregnant or lactating female subjects. 15. 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 subject's safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Immunogenicity; | — |
Countries
China
Contacts
Public ContactChen Guiling
Shulan (Hangzhou) Hospital
Outcome results
None listed