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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-designed Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of HS-10383 in Chinese Adult Subjects With Refractory or Unexplained Chronic Cough (RUCC)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Cough
• Intervention / Treatment: Drug: HS-10383; Drug: HS-10383 Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 276
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-10383 50mg; HS-10383 oral dose 50 mg once a day.	Drug: HS-10383; HS-10383 administered as one 50 mg, 100 mg 200 mg tablet once daily, depending upon randomization.
Experimental: HS-10383 100mg; HS-10383 oral dose 100 mg once a day.	Drug: HS-10383; HS-10383 administered as one 50 mg, 100 mg 200 mg tablet once daily, depending upon randomization.
Experimental: HS-10383 200ng; HS-10383 oral dose 200 mg once a day.	Drug: HS-10383; HS-10383 administered as one 50 mg, 100 mg 200 mg tablet once daily, depending upon randomization.
Placebo Comparator: Placebo; Matching Placebo for HS-10383 oral dose once a day	Drug: HS-10383 Placebo; HS-10383 administered as one 50 mg, 100 mg 200 mg tablet once daily, depending upon randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-Hour Cough Frequency	Assessed using an ambulatory cough monitor	at Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Awake Cough Frequency	Change from baseline in awake cough frequency at week 4;	at Week 4
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
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

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: HS-10383-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No