A Study to Evaluate the Efficacy and Safety of HSK31858 Tablets in Patients with Airway Mucus Hypersecretion

Exclusion criteria

• ✕. Known allergic history to the active ingredient of the investigational drug or other drugs with similar chemical structure;
• ✕. FEV1 accounted for less than 30% of the estimated value after bronchodilator use;
• ✕. Patients who have experienced any degree of acute exacerbation of asthma or are experiencing an acute exacerbation of asthma within 4 weeks prior to screening;
• ✕. Hemoptysis (other than a small amount of bloody sputum or a blood clot smaller than a fingernail) occurs within 4 weeks prior to screening and requires urgent medical intervention;
• ✕. Active infection or acute infection requiring systemic anti-infective therapy within 4 weeks prior to screening.
• ✕. History of malignancy: subjects with basal cell carcinoma, limited squamous cell carcinoma of the skin, or cervical carcinoma in situ will be allowed to enter the study if curative treatment has been completed for at least 12 months prior to signing the informed consent form; subjects with other malignancies will be allowed to enter the study if curative treatment has been completed for at least 5 years prior to signing the informed consent form;
• ✕. Presence of any severe and/or uncontrolled medical condition that, in the judgement of the investigator, affects the safety of the subject or interferes with the evaluation of the medication, including, but not limited to: severe neurological disease, history of serious mental disorders, major cardiovascular disease, diabetes mellitus that is poorly controlled on standardized therapy, presence of prolonged QTcF interval or cardiac arrhythmia, or immunodeficiency disorders;
• ✕. Subjects with a history of liver disease or currently receiving treatment for liver disease during the screening period, including but not limited to acute and chronic hepatitis, cirrhosis or liver failure;