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

Haisco Pharmaceutical Group

Status and phase: Enrolling; Phase 3

Conditions: Non-cystic Fibrosis Bronchiectasis

Treatments: Drug: HSK31858, tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT07616375

HSK31858-302

Details and patient eligibility

About

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

Enrollment: 669 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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669 participants in 1 patient group

HSK31858 40mg

Experimental group

Description:

HSK31858 40mg treat for 96-week

Treatment:

Drug: HSK31858, tablet