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Tests treatment safety and results for Non-cystic Fibrosis Bronchiectasis
Official title A Study to Assess the Efficacy and Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis
ClinicalTrials.gov ID: NCT06660992
What this study is testing
What is HSK31858, tablet?
HSK31858, tablet is an investigational medicine, being studied as a potential treatment for non-cystic fibrosis bronchiectasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase III, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of HSK31858 in non-cystic fibrosis bronchiectasis (NCFBE) participants.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Age ≥18 years and BMI≥18.0 kg/m\^2 at the time of signing the ICF. 2. Chest HRCT showed bronchiectasis affecting one or more lobes and was...
- 3\. Have at least 2 pulmonary exacerbations in the past 12 months before Screening.
- 4\. If long-term treatment with bronchodilators (long-acting β-agonists and/or long-acting muscarinic antagonists) is required, the dose and regimen...
- 5\. The estimated survival time ≥ 12 months. 6. Women must be post-menopausal, surgically sterile, or using highly effective contraception methods...
- 7\. 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 likely can't join if
- 1\. Have a primary diagnosis of COPD or asthma as judged by the Investigator. 2. A history of malignancy (excluding cured basal cell carcinoma of the...
- AST\>2.0×ULN or ALT\>2.0×ULN or TBIL\>1.5×ULN
- eGFR\<60ml/min/1.73m2
- Hb\<90 g/L
- WBC \<3×109 /L
- PLT \<70×109 /L
See the full eligibility criteria
- 1\. Age ≥18 years and BMI≥18.0 kg/m\^2 at the time of signing the ICF. 2. Chest HRCT showed bronchiectasis affecting one or more lobes and was confirmed by a clinician as NCFBE(clinically characterized by chronic cough...
- 3\. Have at least 2 pulmonary exacerbations in the past 12 months before Screening.
- 4\. 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 for at least 3 months before the screening visit...
- 5\. The estimated survival time ≥ 12 months. 6. 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.
- 7\. Males with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.
- 8\. Give their signed study informed consent to participate.
- 1\. Have a primary diagnosis of COPD or asthma as judged by the Investigator. 2. A history of malignancy (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary carcinoma of the thyroid...
- AST\>2.0×ULN or ALT\>2.0×ULN or TBIL\>1.5×ULN
- eGFR\<60ml/min/1.73m2
- Hb\<90 g/L
- WBC \<3×109 /L
- PLT \<70×109 /L
- INR\>1.5ULN，PT\>ULN+3s, or APTT\>ULN+10s. 15. Had participated in a clinical trial of any other drug or medical device in the 3 months prior to the screening (a drug or medical device treated with a clinical trial) or...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Yixingcun, Jiangxi, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Yixingcun, Jiangxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.