A Single-Arm Phase Ic Clinical Study of XKH001 Injection in Patients With Allergic Asthma After Multiple Doses

Exclusion Criteria

• •Subjects who meet any of the following criteria must be excluded from this study:
• •1. Subjects who are current smokers or with a smoking history of \> 10 pack-years. Subjects who have quit smoking need to have quit smoking for at least 12 months before enrollment;
• •2. Subjects with hospitalization or emergency visits due to respiratory system and/or asthma-related conditions within 6 months before screening;
• •3. Subjects with worsening or exacerbation of asthma, or the use of systemic glucocorticoid therapy within 6 weeks before or during screening;
• •4. Subjects with a history of alcoholism or drug abuse;
• •5. Subjects who are allergic to the investigational product or any component of the formulation of the investigational product or have a history of allergy to protein drugs;
• •6. Subjects with elevated total IgE due to reasons other than allergens (e.g. parasitic infections and hematological disorders);
• •7. Subjects who have undergone allergen-specific immunotherapy or used immunosuppressants within 3 months before screening;
• •8. Subjects who have used biologics (such as monoclonal antibodies), including investigational biologics, within 6 months before screening;
• •9. Subjects who have received any anti-IgE antibody treatment or bronchial thermoplasty within 12 months before screening;
• •10. Subjects who have received live (attenuated) viral/bacterial vaccines or intravenous (IV) immunoglobulins (IgG) within 4 weeks before screening;
• •11. Subjects with respiratory system infection or have received a major surgery within 8 weeks before screening;
• •12. Subjects with a combination of other lung diseases such as COPD, bronchiectasis, or lung fibrosis;
• •13. Subjects with a history of contraindications to choline, such as myocardial infarction or stroke within the past 3 months, known heart disease, uncontrolled hypertension, aortic or brain aneurysm;
• •14. Subjects with neoplasm malignant within 5 years before screening or current neoplasm malignant;
• •15. Subjects with a history of autoimmune diseases, known family history of inherited immunodeficiency disorders, or recurrent infections suggestive of possible immunodeficiency;
• •16. Subjects who had or currently have active tuberculosis, or active infection requiring hospitalization or IV antibiotic treatment within 3 months before screening;
• •17. Subjects with positive HBsAg in 5 items of hepatitis B serology (if HBsAg is negative, HBcAb is positive, and HBsAb is negative, HBV-DNA quantitative test is required to be performed \[the subject will be excluded if the test result is positive\]), hepatitis C antibody, treponema pallidum antibody, and HIV antigen/antibody;
• •18. Subjects who have participated in other investigational drug clinical studies within 30 days or 5 half-lives of the study drug (whichever is longer). If a subject has received an investigational drug of a biological product, e.g., a monoclonal antibody, the subject is required to have received the biological product at least 6 months before the screening visit;
• •19. Subjects with severe, progressive, or uncontrolled diseases such as liver, kidney, gastrointestinal, cardiovascular, hematopoietic, genitourinary, endocrine, nervous, immune system disorders, and other conditions that investigators consider unsuitable for inclusion in this study.