Actively Recruiting
Phase 3 Single-arm, Open-label, Multicenter Study to Assess the Safety of HSK31858 in Participants With Non-cystic Fibrosis Bronchiectasis
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2026-06-01
669
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
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 drug's 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.
CONDITIONS
Brief Title
A Study to Assess the Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form
- Previously participated in the HSK31858-301 study, completed at least randomization and taken the first dose of medication
- Long-term bronchodilator treatment dose and regimen must remain stable throughout the study if required
- Women must be post-menopausal, surgically sterile, or using highly effective contraception from Day 1 to at least 30 days after last dose
- Males with female partners of childbearing potential must use effective contraception from Day 1 to at least 90 days after last dose
You will not qualify if you...
- Experienced serious adverse events related to the investigational drug or required permanent treatment discontinuation in the HSK31858-301 study
- Have unstable clinical conditions likely to affect safety or study results, including cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic, psychiatric, or major physiological dysfunction
- Pregnant or lactating women
- Other conditions judged by investigators as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 96 weeks
Participants receive HSK31858 40mg tablets for 96 weeks to assess safety and efficacy in treating non-cystic fibrosis bronchiectasis.
Trial Site Locations
Total: 1 location
1
Yixing People's Hospital, Yixing, Jiangxi Recruiting
Yixingcun, Jiangxi, China
Actively Recruiting
Research Team
G
Guan Wei Jie
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here