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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaisco Pharmaceutical Group Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • HSK31858, tablet

Treatment groups

669 Participants
are divided into 1 treatment group