NCT07616375RecruitingPhase 3
A Study to Assess the Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis
Phase 3 Single-arm, Open-label, Multicenter Study to Assess the Safety of HSK31858 in Participants With Non-cystic Fibrosis Bronchiectasis
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
This is a phase III, single-arm, open-label, multicenter study to assess the safety of HSK31858 in non-cystic fibrosis bronchiectasis (NCFBE) participants.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 669 (estimated)
- First submitted
- 23 May 2026
- Start date
- 28 Sept 2025
- Primary completion date
- 10 Jan 2029
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Diseases
- Cystic fibrosis
- NCT number
- NCT07616375
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 669
- From 28 Sept 2025 to the primary completion date, 10 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1.In the HSK31858-301 study, there were cases of serious adverse events related to the investigational drug or subjects who were assessed by the investigators as requiring permanent discontinuation of the treatment.
- 2\. Any other unstable clinical condition, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic, psychiatric, or major physiological dysfunction, that the investigator considers to be (a) likely to affect patient safety throughout the study; (b) Influence the results of the study and its interpretation; (c) impeding the patient\'s ability to complete the entire study.
- 3.Pregnancy and lactation. 4.The investigators judged that there were other conditions that were not suitable for participation in the study.
Who the study is looking for
- 1.Voluntarily sign the informed consent form; 2.Had previously participated in the HSK31858-301 study (having completed at least the randomization and having taken the first dose of medication); 3.If long-term treatment with bronchodilators (long-acting β-agonists and/or long-acting muscarinic antagonists) is required, the dose and regimen should remain stable throughout the study period.
- 4.Women must be post-menopausal, surgically sterile, or using highly effective contraception methods from Day 1 to at least 30 days after the last dose.
- 5\. Males with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yixing People's Hospital, Yixing, Jiangxi Recruiting Coordinator of this site? Confirm its status | Yixingcun | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.