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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.
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Yixing People's Hospital, Yixing, Jiangxi Recruiting
Coordinator of this site? Confirm its status
YixingcunChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.