A Study to Assess the Efficacy and Tolerance of HRS-2261 in Subjects With Refractory Chronic Cough

Exclusion Criteria

• •1. Patients diagnosed with chronic obstructive pulmonary disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis (IPF), and endobronchial tuberculosis;
• •2. Patients with a history of chronic bronchitis;
• •3. Patients with a history of upper or lower respiratory tract infection, or acute exacerbation of respiratory disease, or significant changes in chest imaging within 4 weeks prior to baseline period;
• •4. Current smokers, smokers who have quit smoking (within 6 months), or former smokers who consume more than 20 packs of cigarettes per year;
• •5. Those with abnormal taste within 3 months prior to previous diagnosis or screening;
• •6. Malignant disease within 5 years or less before signing the informed consent, except for basal cell or squamous cell skin cancer or cervical cancer in situ after appropriate treatment;
• •7. Currently taking or having taken an angiotensin-converting enzyme inhibitor in the 3 months prior to screening;
• •8. Those who are currently taking or have used any antitussive medication within the week prior to screening;
• •9. Patients who had used oral steroids or antiallergy drugs within 1 week prior to screening;
• •10. Screening or baseline 1 second rate \< 60%;
• •11. Poorly controlled hypertension;
• •12. Alanine aminotransferase or aspartate aminotransferase more than 2 times the upper limit of normal in screening period or baseline period;
• •13. Estimated glomerular filtration rate (eGFR) \< 30mL/min/1.73m2 or eGFR≥30mL/min/1.73m2 and \<50mL/min/1.73m2 with unstable renal function during screening;
• •14. Use of 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. A recent history of drug or alcohol abuse or dependence (within the past 1 year);
• •16. Participants enrolled in clinical trials of any drug or medical device within 3 months prior to screening, or within 5 half-lives of test drugs before screening, whichever is longer;
• •17. Any past or present circumstances, determined by the investigator or sponsor, make the subject unfit for admission to the study.