A Study of HS-10383 in Chinese Adult Subjects With Refractory or Unexplained Chronic Cough (RUCC)

Launched by JIANGSU HANSOH PHARMACEUTICAL CO., LTD. · Jan 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called HS-10383 to see if it can help adults in China who have a long-lasting cough that doesn't seem to have a clear cause, known as refractory or unexplained chronic cough (RUCC). The trial will compare the effects of HS-10383 with a placebo, which is a harmless pill that doesn’t contain the active medication. This study is in its early stages (Phase 2), and it aims to understand how well the medication works, how safe it is, and how the body processes it.

To participate, individuals need to be between 18 and 70 years old and have been experiencing this type of cough for at least a year. They should also be in good health overall, without serious lung diseases or other conditions that could complicate the study. Participants will be closely monitored throughout the trial, and they will receive detailed information about what to expect, including any potential side effects. Since the trial is not yet recruiting, those interested will have to wait for it to begin before they can apply.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects should have a full understanding of the study contents, process, and possible adverse reactions, and voluntarily sign the informed consent form;
• • 2. Subjects aged 18-70 years (including the critical value) with RUCC ≥1 year (diagnosis of RUCC according to the Expert Consensus on Diagnosis and Treatment of Refractory Chronic Cough in China \[Released in 2021\]);
• • 3. Subjects whose serum pregnancy test is negative in both screening and baseline visits;
• Exclusion Criteria:
• • 1. Subjects who are diagnosed with chronic obstructive pulmonary disease, bronchiectasis, idiopathic pulmonary fibrosis and other serious lung diseases;
• • 2. Any physiological or mental disease or condition that may increase study risks or interfere with the conduct of the study or affect the ability to complete this study in the opinion of the investigator, such as medical history of depression;
• • 3. Subjects who cannot meet the requirements for piror treatment or who cannot adhere to the concomitant treatment as specified in Section 6.7-Prior/concomitant medications and non-drug treatment.
• • 4. Subjects with positive hepatitis A IgM antibody, hepatitis C antibody (HCVAb), syphilis antibody or human immunodeficiency virus (HIV) antibody at screening visit; subjects with positive hepatitis B surface antigen (HBsAg) at screening (except for quantitative detection result of HBV-DNA is below the lower limit of the detection reference range).
• • 5. Any former smoker with more than 20 packs/year; or have quited smoking for less than 6 months; or subjects who are still smoking (including e-cigarettes);
• • 6. Subjects who have a history of serious drug, food or environmental allergies, or who are known to be allergic to the ingredients of investigational product;
• • 7. History of drug dependence,drug or alcohol abuse in the past year;
• • 8. Female subjects who are pregnant or breastfeeding;
• • 9. Subjects who have previously received anything that may affect drug absorption, including but not limited to: gastrectomy, gastroplasty, any type of weight-loss surgery, vagotomy or enterotomy;
• • 10. Subjects who have been vaccinated within 30 days before screening visit, or have a vaccination plan during the whole study period.