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

NCT07616375 | Recruiting Phase 3

• 1 other identifier: HSK31858-302
• Study Type: interventional
• Target: 669
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-cystic Fibrosis Bronchiectasis

Keywords

non-cystic fibrosis bronchiectasis

Outcome Measures

Primary Outcomes (1)

• AE

  Occurrence of adverse events

  week 96

Secondary Outcomes (4)

• Frequency of pulmonary exacerbations

  week 96

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

  week 96

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

  week 96

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

  week 96

Study Arms (1)

HSK31858 40mg

EXPERIMENTAL

HSK31858 40mg treat for 96-week

Drug: HSK31858, tablet

Interventions

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

HSK31858 40mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Pregnancy and lactation. 4.The investigators judged that there were other conditions that were not suitable for participation in the study.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Yixing People's Hospital, Yixing, Jiangxi Recruiting

Yixingcun, Jiangxi, China

RECRUITING

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Guan Wei Jie

CONTACT

86-13826042052; battery203@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 1, 2026
• Study Start: September 28, 2025
• Primary Completion (Estimated): January 10, 2029
• Study Completion (Estimated): April 3, 2029
• Last Updated: June 1, 2026

Record last verified: 2025-10

Locations

CN (1)