Phase 3 Open-label Study to Evaluate the Safety of HSK31858 in Adults With Non-Cystic Fibrosis Bronchiectasis

What this Trial Is About

This trial investigates the safety of HSK31858, a novel drug developed to reduce pulmonary exacerbations in people with non-cystic fibrosis bronchiectasis NCFBE. It is a phase III, single-arm, open-label, multicenter study aiming to evaluate the safety profile of HSK31858 in this patient group. The study is sponsored by Haisco Pharmaceutical Group Co., Ltd. and focuses on participants who have previously been involved in an earlier related study of the drug. Participants will receive HSK31858 at a dose of 40 mg once daily over a 96-week treatment period. This treatment phase is the main part of the study, where the drugs impact on health and lung function will be closely monitored. The study does not involve a comparison group or placebo, and all participants will receive the active drug. During the study, participants will undergo regular evaluations including monitoring of adverse events, lung function tests such as forced expiratory volume in 1 second FEV1, assessment of respiratory symptoms through quality of life questionnaires, and sputum analysis. These assessments will help researchers understand the safety and effects of HSK31858 over nearly two years. The total study duration for each participant corresponds to the 96-week treatment period, with ongoing safety and health monitoring throughout.

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