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

NCT ID: NCT06246565

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-06-01

Brief 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).

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.

Conditions

Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HS-10383 50mg

HS-10383 oral dose 50 mg once a day.

Group Type: EXPERIMENTAL

HS-10383

Intervention Type: DRUG

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

HS-10383 100mg

HS-10383 oral dose 100 mg once a day.

Group Type: EXPERIMENTAL

HS-10383

Intervention Type: DRUG

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

HS-10383 200ng

HS-10383 oral dose 200 mg once a day.

Group Type: EXPERIMENTAL

HS-10383

Intervention Type: DRUG

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

Placebo

Matching Placebo for HS-10383 oral dose once a day

Group Type: PLACEBO_COMPARATOR

HS-10383 Placebo

Intervention Type: DRUG

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

Interventions

HS-10383

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

Intervention Type: DRUG

HS-10383 Placebo

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HS-10383-201

Identifier Type: -

Identifier Source: org_study_id