NCT06660992

A Study to Assess the Efficacy and Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis

Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of HSK31858 in Participants With Non-cystic Fibrosis Bronchiectasis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 669 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of HSK31858 in non-cystic fibrosis bronchiectasis (NCFBE) participants.

Conditions

• Non-cystic Fibrosis Bronchiectasis

Interventions

Type	Name	Description
DRUG	HSK31858, tablet	HSK31858 is a novel inhibitor of DPP1 developed by Hisco Pharmaceutical and can reduce pulmonary exacerbations over a 52-week treatment period in patients with non-cystic fibrosis bronchiectasis
DRUG	Placebo	the placebo comparator of study

Timeline

• Start date: 2024-09-30
• Primary completion: 2026-11-28
• Completion: 2027-01-27
• First posted: 2024-10-28
• Last updated: 2024-10-28

Locations

2 sites across 1 country: China