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NCT Number: NCT07616375

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

This is a phase III, single-arm, open-label, multicenter study to assess the safety of HSK31858 in non-cystic fibrosis bronchiectasis (NCFBE) participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yixing People's Hospital, Yixing, Jiangxi Recruiting

Yixingcun, Jiangxi, China

Location status: Recruiting

Location contact

Feng Yan Yan

CONTACT

[email protected]

86-13812558080

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

  • Males with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

HSK31858, tablet

Drug

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

Primary outcomes

  1. AE

    Time frame: week 96

    Occurrence of adverse events

Secondary outcomes

  1. Frequency of pulmonary exacerbations

    Time frame: week 96

  2. Change from Baseline(Screening) in forced expiratory volume in 1 second (FEV1)

    Time frame: week 96

  3. Change from Baseline in the Respiratory Symptoms Domain Score of the Quality of Life (QOL) Bronchiectasis questionnaire

    Time frame: week 96

    score from 0 to 100

  4. Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score

    Time frame: week 96

    score from 0 to 8

Study contacts

Contact information is provided by the study sponsor or research team.

Guan Wei Jie

CONTACT

[email protected]

86-13826042052

Sponsors and collaborators

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

Phase 3 Single-arm, Open-label, Multicenter Study to Assess the Safety of HSK31858 in Participants With Non-cystic Fibrosis Bronchiectasis

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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