Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2025-12-24 @ 12:55 PM
NCT ID:
NCT06992661
Eligibility Criteria:
ICD patients:
Inclusion Criteria:
1. Age ≥40 years, any gender
2. Diagnosed or suspected ILD (IPF or CTD-ILD) based on HRCT or thin-section CT
3. FVC ≥40% predicted, DLCO ≥40% predicted, FEV1/FVC ≥0.7
4. Able to tolerate bronchoscopy
5. Willing to use effective contraception during study
6. Able to abstain from coffee/tea products 48h before to 48h after dosing
7. Capable of proper inhaler use
Exclusion Criteria:
1. Pregnancy or lactation
2. Allergy to study drug components
3. Active respiratory infection or acute cardiopulmonary disease
4. Abnormal liver function (ALT/AST/GGT \> ULN or total bilirubin \> ULN)
5. Recent smoking (within 6 months) or alcohol abuse
6. Participation in other clinical trials within 3 months
7. Blood donation ≥400mL within 3 months
8. HBV DNA ≥2000 IU/mL or HCV RNA ≥1000 IU/mL or HIV positive
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT06992661
Study Brief:
Protocol Section:
NCT06992661