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

NCT06246565 | Not Yet Recruiting Phase 2

• 1 other identifier: HS-10383-201
• Study Type: interventional
• Target: 276
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Cough

Outcome Measures

Primary Outcomes (1)

• 24-Hour Cough Frequency

  Assessed using an ambulatory cough monitor

  at Week 4

Secondary Outcomes (3)

• Awake Cough Frequency

  at Week 4

• Change from Baseline in Cough Severity Visual Analogue Scale at Week 2 and Week 4;

  at Week 2 and Week 4

• Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 2 and Week 4.

  at Week 2 and Week 4

Study Arms (4)

HS-10383 50mg

EXPERIMENTAL

HS-10383 oral dose 50 mg once a day.

Drug: HS-10383

HS-10383 100mg

EXPERIMENTAL

HS-10383 oral dose 100 mg once a day.

Drug: HS-10383

HS-10383 200ng

EXPERIMENTAL

HS-10383 oral dose 200 mg once a day.

Drug: HS-10383

Placebo

PLACEBO COMPARATOR

Matching Placebo for HS-10383 oral dose once a day

Drug: HS-10383 Placebo

Interventions

HS-10383 DRUG

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

HS-10383 100mg; HS-10383 200ng; HS-10383 50mg

HS-10383 Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects should have a full understanding of the study contents, process, and possible adverse reactions, and voluntarily sign the informed consent form;
• 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 \[Released in 2021\]);
• Subjects whose serum pregnancy test is negative in both screening and baseline visits;

You may not qualify if:

• Subjects who are diagnosed with chronic obstructive pulmonary disease, bronchiectasis, idiopathic pulmonary fibrosis and other serious lung diseases;
• 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;
• 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.
• 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).
• 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);
• 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;
• History of drug dependence,drug or alcohol abuse in the past year;
• Female subjects who are pregnant or breastfeeding;
• 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;
• Subjects who have been vaccinated within 30 days before screening visit, or have a vaccination plan during the whole study period.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-01