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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06246565
Other study ID # HS-10383-201
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date March 1, 2024
Est. completion date June 1, 2026

Study information

Verified date January 2024
Source Jiangsu Hansoh Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-designed phase 2 clinical trial to evaluate the efficacy, safety and pharmacokinetic (PK) characteristics of HS-10383 in Chinese adult subjects with refractory or unexplained chronic cough (RUCC).


Description:

The primary objectives of this study are to evaluate the efficacy of HS-10383 in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of HS-10383. The primary hypothesis is that at least one dose of HS-10383 is superior to placebo in reducing coughs per hour (over 24 hours) at Week 4.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 276
Est. completion date June 1, 2026
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HS-10383
HS-10383 administered as one 50 mg, 100 mg 200 mg tablet once daily, depending upon randomization.
HS-10383 Placebo
HS-10383 administered as one 50 mg, 100 mg 200 mg tablet once daily, depending upon randomization.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary 24-Hour Cough Frequency Assessed using an ambulatory cough monitor at Week 4
Secondary Awake Cough Frequency Change from baseline in awake cough frequency at week 4; at Week 4
Secondary Change from Baseline in Cough Severity Visual Analogue Scale at Week 2 and Week 4; Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity. at Week 2 and Week 4
Secondary Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 2 and Week 4. The LCQ is a patient-reported quality of life (QOL) measure of chronic cough,the higher scores mean a better outcome. at Week 2 and Week 4
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