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RECRUITING
NCT06660992
PHASE3

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

Sponsor: Haisco Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

669

Start Date

2024-09-30

Completion Date

2027-01-27

Last Updated

2024-10-28

Healthy Volunteers

No

Interventions

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

Locations (2)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Yixing People's Hospital

Yixingcun, Jiangxi, China