About this trial
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study. It Aims aims to evaluate the efficacy and safety of different doses of SYH2059 tablets compared with placebo in adult patients with IPF, observe the PK profile of SYH2059 tablets in adult IPF patients, and assess the population pharmacokinetic (PPK) profile, exposure-response (E-R) relationship, as well as the changing trends of blood biomarkers.
Eligibility criteria
Qualifiers
1. Age ≥ 40 years, regardless of gender;
2. The investigator confirms the clinical diagnosis of IPF in participants based on chest HRCT, surgical lung biopsy, or transbronchial lung cryobiopsy (if available) performed during the screening period or within 1 year prior to screening (see Appendix 13.7 for details);
3. FVCpp ≥ 45% during the screening period;
4. Hemoglobin-corrected DLCOpp ≥ 25% and < 90% during the screening period;
Disqualifiers
1. Interstitial lung disease other than IPF.
2. Airway obstruction during screening (FEV₁/FVC < 0.7), or emphysema greater than pulmonary fibrosis on HRCT.
3. Confirmed or suspected acute exacerbation of IPF within 3 months prior to screening.
4. Investigator judgment that IPF severity showed sustained improvement during the 12 months prior to screening, based on changes in FVC, DLCO and/or HRCT findings.
Trial design
Treatments tested in this trial
- SYH2059 Tablets
- Placebo