NCT06246565

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	HS-10383	HS-10383 administered as one 50 mg, 100 mg 200 mg tablet once daily, depending upon randomization.
DRUG	HS-10383 Placebo	HS-10383 administered as one 50 mg, 100 mg 200 mg tablet once daily, depending upon randomization.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-09-01
• Completion: 2026-06-01
• First posted: 2024-02-07
• Last updated: 2024-03-04