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

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

Study Overview

• Status: Recruiting
• Conditions: Non-cystic Fibrosis Bronchiectasis
• Intervention / Treatment: Drug: HSK31858, tablet

• Study Type: Interventional
• Enrollment (Estimated): 669
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Guan Wei Jie; Phone Number: 86-13826042052; Email: battery203@163.com

Study Locations

• China
  • Jiangxi
    • Yixingcun, Jiangxi, China
      • Recruiting
      • Yixing People's Hospital, Yixing, Jiangxi Recruiting
      • Contact: Feng Yan Yan; Phone Number: 86-13812558080; Email: staff622@Yxph.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

  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.

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.

  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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HSK31858 40mg; HSK31858 40mg treat for 96-week	Drug: HSK31858, tablet; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE	Occurrence of adverse events	week 96

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	score from 0 to 100	week 96
Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score	score from 0 to 8	week 96

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2025
• Primary Completion (Estimated): January 10, 2029
• Study Completion (Estimated): April 3, 2029

Study Registration Dates

• First Submitted: May 23, 2026
• First Submitted That Met QC Criteria: May 23, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 23, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: non-cystic fibrosis bronchiectasis
• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Dosage Forms; Tablets
• Other Study ID Numbers: HSK31858-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No