NCT06820749

A Study to Evaluate the Efficacy and Safety of HSK31858 Tablets in Patients with Airway Mucus Hypersecretion

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of HSK31858 Tablets in Patients with Airway Mucus Hypersecretion in Chronic Airway Inflammatory Diseases

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 309 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, randomised, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of HSK31858 in patients with airway mucus hypersecretion in chronic airway inflammatory diseases

Conditions

• Asthma Bronchiale
• Bronchiectasis
• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	HSK31858	HSK31858 is a novel inhibitor of DPP1 developed by Hisco Pharmaceutical and can reduce pulmonary exacerbations over a 12-week treatment period in patients with airway mucus hypersecretion in chronic airway inflammatory diseases
DRUG	Placebo	the placebo comparator of study

Timeline

• Start date: 2024-12-10
• Primary completion: 2026-04-23
• Completion: 2026-06-22
• First posted: 2025-02-11
• Last updated: 2025-02-20

Locations

1 site across 1 country: China