Pharmacokinetics, Pharmacodynamics, Safety, and Preliminary Efficacy of Subcutaneous Injection of SHR-1905 in Adolescent Asthmatic Subjects - an Open-label, Single-dose Phase II Clinical Study

Exclusion Criteria

• •1. Combined with clinically significant lung disease other than asthma
• •2. A combination of diseases other than asthma that may affect lung function
• •3. Combined with other pulmonary or systemic diseases associated with eosinophil elevation, or other diseases associated with eosinophil elevation that the investigators believe need to be excluded.
• •4. Bronchial thermoplasty or bronchial cryoablation were performed within 1 year prior to baseline.
• •5. Acute asthma attacks requiring systemic glucocorticoid use for ≥3 days occurred within 1 month prior to baseline.
• •6. Systemic glucocorticoids were used as maintenance therapy for the first 3 months of the baseline period.
• •7. Acute episodes of life-threatening asthma occurred within 5 years prior to baseline.
• •8. Allergen immunotherapy was administered 8 weeks prior to baseline.
• •9. Non-selective beta-blockers were used for the first 4 weeks of the baseline period.
• •10. Participated in clinical trials of any drug or medical device within 12 weeks prior to screening.
• •11. Severe trauma or major surgery in the 6 months prior to baseline.
• •12. History of malignant tumor.
• •13. Combined with serious other systemic diseases.
• •14. Combined with immunodeficiency disease.
• •15. A history of infection requiring treatment with systemic anti-infective drugs in the 4 weeks prior to baseline.
• •16. Parasitic infection was present in the 6 months prior to baseline.
• •17. Abnormal laboratory tests during screening or baseline. Screening or baseline ECG results were abnormal and clinically significant.
• •18. At the time of screening, smokers were still smoking or had quit for less than 6 months, or had a smoking history of ≥10 pack-years.
• •19. Alcohol consumption within 1 month prior to baseline.
• •20. History of drug abuse and drug use within 1 year before screening.
• •21. Those who had a history of blood donation within 4 weeks prior to baseline, or had significant blood loss, or had received a blood transfusion within 8 weeks.
• •22. People who received live (attenuated) vaccine or viral vector vaccine within 8 weeks prior to the baseline period or planned to receive it during the trial.
• •23. Researchers and relevant staff of research centres or others directly involved in programme implementation.
• •24. The investigator considers that there are any circumstances that may cause subjects to be unable to complete the study or present a significant risk to subjects or other factors that may reduce the likelihood of enrollment.