A Study to Evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients With Eosinophil Phenotype

• Status: Not yet recruiting
• Trial end date: 2024-06-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

1. Aged 18 to 75years (inclusive).

2. Weight ≥40 kg.

3. History of asthma≥ 1 year.

4. Documented treatment with Medium or high daily dose inhaled corticosteroid with additional controller medication within the 3 months prior to randomization.

5. Previously confirmed history of one or more asthma exacerbations within 1 year prior to randomization.

6. Blood eosinophils of ≥150 cells/µL at screening and baseline.

7. Pre-Bronchodilator FEV1% pred≥40% and<80% at screening and baseline.

8. Asthma Control Questionnaire-6 score≥1.5.

9. Use highly effective contraceptive measures.

10. Willing to sign the informed consent form to participate in this study.

Exclusion Criteria:

1. Subjects with Clinically significant pulmonary diseases；

2. Subjects with other diseases that could lead to elevated eosinophils；

3. Subjects with Immunodeficiency；

4. Poorly controlled hypertension;

5. Subjects with severe cerebrovascular disease;

6. Subjects with infection history requiring clinical intervention；

7. Subjects with parasitic infection；

8. Diagnosed Malignant tumor within 5 years prior to randomization;

9. Used non-selective β-blockers within 1 week prior to randomization;

10. Used either 5-lipoxygenase inhibitor or Phosphodiesterase-4 inhibitor within 1 week prior to randomization;

11. Blood donation or massive blood loss, or transfusion of blood products or immunoglobulins within 4 weeks prior to randomization;

12. Live attenuated vaccine inoculated within 4 weeks before randomization;

13. Allergen Immunotherapy within 8 weeks prior to randomization；

14. Used systemic immunosuppressants or immunomodulators, or biologics or Th2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug;

15. Bronchial thermoplasty within 1 year prior to randomization；

16. Subjects have planned Surgery or other medical procedures that may affect evaluation during the study period;

17. Subjects with significant laboratory abnormality at screening；

18. Subjects have prolonged QTc interval or other electrocardiogram abnormality with significant safety risk at screening;

19. Current smokers or ex-smokers who have given up smoking for <6 months ，or positive smoke test, and/or have a smoking pack history of > 10 pack years;

20. History of drug or substance abuse or alcohol abuse within 1 year prior to screening;

21. Subjects participated another clinical studies and received active drug within 30 days or 5 half-lives prior to screening;

22. Subjects is pregnant, lactating,or planning to become pregnant;

23. Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents;

24. Other conditions unsuitable for participation in the study per investigator judgement.