A Phase 2 Study of HW091077 in Participants With Refractory Chronic Cough Or Unexplained Chronic Cough (RCC/UCC).

A Randomized，Double-Blind, Multicenter，Placebo-Controlled, Parallel-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of HW091077 in Participants With Refractory Chronic Cough or Unexplained Chronic Cough (RCC/UCC).

This is a randomized, multicenter, double-blind, placebo-controlled, parallel-designed phase 2 clinical trial to evaluate the efficacy, safety and pharmacokinetic (PK) characteristics of HW091077 in Chinese adult subjects with refractory chronic cough or unexplained chronic cough (RCC/UCC).

Study Overview

• Status: Not yet recruiting
• Conditions: Refractory Chronic Cough
• Intervention / Treatment: Drug: HW091077; Drug: Matching placebo to HW091077

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Aged between 18 and 80 years;
• Diagnosed with refractory chronic cough or unexplained chronic cough, with a cough lasting for ≥1 year;
• Chest CT at screening shows no abnormalities that the investigator believes may lead to chronic cough;
• Cough severity VAS score ≥40 mm ;
• Female participants of childbearing potential must have a negative pregnancy test and must not be breastfeeding; male and female participants must have no plans for pregnancy during the entire clinical trial and within 6 months after the last dose, and agree to use medically accepted reliable contraceptive methods during the trial and within 6 months after the last dose;
• Fully understand the study, voluntarily sign the informed consent form, and be able to comply with the study procedures and follow-up requirements.

Exclusion Criteria:

• Currently smoking, or having quit smoking within 12 months prior to screening;
• A smoking history of >20 pack-years;
• Ongoing exposure to inhaled toxic substances within 12 months prior to screening or currently;
• A history of drug abuse or alcoholism (weekly alcohol consumption of 14 units of alcohol: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
• Diagnosed with chronic obstructive pulmonary disease (COPD), chronic bronchitis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, bronchial asthma (except for cough variant asthma), or other airway/respiratory diseases that may affect coughing;
• Respiratory tract infection or significant changes in lung status within 4 weeks prior to screening;
• FEV1/FVC)<60%;
• Clinically significant electrocardiogram abnormalities, such as QTc interval ≥450 ms, long QT syndrome, etc.;
• Use of angiotensin-converting enzyme inhibitors (ACEIs) within 3 months prior to screening;
• Plans to initiate new treatment for RCC/UCC during the trial period;
• Taste disturbance within 1 month prior to screening;
• Use of any P2X3 receptor antagonist within 1 year prior to screening;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HW091077 oral dose1; HW091077 oral dose1 once a day.	Drug: HW091077; HW091077 oral tablet, oral, QD
Experimental: HW091077 dose2; HW091077 oral dose2 once a day.	Drug: HW091077; HW091077 oral tablet, oral, QD
Placebo Comparator: placebo; Matching Placebo for HW091077 oral dose once a day	Drug: Matching placebo to HW091077; Matching placebo to HW091077 oral tablet, oral, QD

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
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
Change from Baseline in Cough Severity Visual Analogue Scale (VAS) 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

Collaborators and Investigators

• Sponsor: Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Cough
• Other Study ID Numbers: HW091077-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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