NCT07616375 A Study to Assess the Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis
| NCT ID | NCT07616375 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Haisco Pharmaceutical Group Co., Ltd. |
| Condition | Non-cystic Fibrosis Bronchiectasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 669 participants |
| Start Date | 2025-09-28 |
| Primary Completion | 2029-01-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 669 participants in total. It began in 2025-09-28 with a primary completion date of 2029-01-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07616375 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-cystic Fibrosis Bronchiectasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07616375 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 669 participants.
Is NCT07616375 currently recruiting?
Yes, NCT07616375 is actively recruiting participants. Contact the research team at battery203@163.com for enrollment information.
Where is the NCT07616375 trial being conducted?
This trial is being conducted at Yixingcun, China.
Who is sponsoring the NCT07616375 clinical trial?
NCT07616375 is sponsored by Haisco Pharmaceutical Group Co., Ltd.. The trial plans to enroll 669 participants.