Chronic inflammatory disease of the airway with high secretion of airway mucus
Conditions
Interventions
HSK31858 tablets 20 mg group:HSK31858 tablets 20 mg
HSK31858 tablets 40 mg group:HSK31858 tablets 40 mg
Placebo group:Placebo
Sponsors
Beijing Chao-Yang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Able to fully understand and voluntarily sign the informed consent form; 2.Able to fully understand and voluntarily sign the informed consent form; 3.Currently suffering from chronic airway inflammatory diseases (bronchiectasis, chronic obstructive pulmonary disease, asthma); 4.During the screening period (V1) and baseline (V2), participants had symptoms of excessive phlegm production (>=10ml of sputum per day). 5.If the participant is using background medications, they must have been on stable doses of all such medications other than expectorants for at least one month prior to screening. 6.Fertile female participants or male participants with fertile female partners must agree not to have plans for pregnancy from signing the informed consent form until 3 months after the last dose, and must voluntarily take appropriate contraceptive measures. All women of childbearing age must have a negative pregnancy test during the screening period. 7.The participant can communicate well with the researcher and is able to complete the study according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Known allergy to the active ingredient of the investigational drug or to other chemically similar medications; 2.Post-bronchodilator FEV1 is less than 30% of the predicted value; 3.Exclude patients who have experienced any degree of acute exacerbation of their disease in the past four weeks or are currently experiencing an acute exacerbation. 4.Within the past 4 weeks, there has been hemoptysis (excluding traces of blood-streaked sputum or blood clots smaller than a fingernail), necessitating urgent medical intervention. 5.Select individuals who had active or acute infections requiring systemic anti-infective treatment within the past four weeks. 6.History of malignant tumors: Participants with basal cell carcinoma, localized squamous cell carcinoma of the skin, or cervical carcinoma in situ are eligible for this study if they have completed curative treatment at least 12 months before signing the informed consent form. Participants with other types of malignant tumors are eligible if they have completed curative treatment at least 5 years before signing the informed consent form. 7.Any severe or uncontrolled medical conditions that the investigator believes may affect the safety of the participant or the evaluation of the drug, including but not limited to: severe respiratory diseases, major cardiovascular diseases, severe neurological diseases, a history of severe mental disorders, poorly controlled diabetes despite standard treatment, prolonged QTcF interval or persistent arrhythmias, and immunodeficiency diseases. 8.Participants with a history of liver disease or currently undergoing liver disease treatment, including but not limited to acute or chronic hepatitis, liver cirrhosis, or liver failure (excluding mild to moderate non-alcoholic fatty liver); 9.Uncontrolled hypertension (systolic blood pressure >=160 mmHg during screening or baseline, and/or diastolic blood pressure >=100 mmHg); 10.Screening period and baseline laboratory abnormalities: a. White blood cell count 2×ULN (upper limit of normal), or aspartate aminotransferase (AST) > 2×ULN, or total bilirubin (TBIL) > 1.5×ULN; c. Patients with moderate to severe renal insufficiency (estimated glomerular filtration rate eGFR < 60 ml/min/1.73 m^2, calculated using the simplified MDRD formula); d. Positive HIV antibody test during screening, or positive syphilis antibody test, active hepatitis B virus infection (positive HBsAg and HBV-DNA load above the detection limit) or active hepatitis C virus infection (positive HCV antibody and HCV-RNA load above the detection limit). 11.Exclusion criteria include participation in any other drug or medical device clinical trials within the past month, or having participated in a drug clinical trial within less than five half-lives of the last drug administration. 12.Exclude those who have taken medications that may cause excessive keratinization within the past 4 weeks, such as tumor necrosis factor alpha antagonists. 13.Patients who have used strong inducers or inhibitors of CYP3A within 14 days or 5 half-lives before the first administration of the investigational drug (whichever period is longer); 14.Combining diseases related to the onset of non-genetic palmoplantar keratoderma, such as myxedema and chronic lymphedema. 15.According to researchers, there were periodontal diseases that affected the stud
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 24-hour sputum volume after 12 weeks of treatment compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| HSK31858 Score the difficulty of sputum production;Sputum trait score;Sputum viscosity score;Cough severity score;Cough and sputum assessment questionnaire;Adverse events;Vital signs (temperature, blood pressure, pulse, respiratory rate);Physical examination indicators;12-lead ECG data;Laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function) data; | — |
Countries
China
Contacts
Public ContactTong Zhaohui; An Li
Beijing Chao-Yang Hospital, Capital Medical University
Outcome results
None listed