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.
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;
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.
Parallel
SYH2059 Tablets
DrugTake twice daily, about 12 hours apart, after meals, for 12 weeks.
Placebo
DrugTake twice daily, about 12 hours apart, after meals, for 12 weeks.
Change in FVC from baseline (mL)
FVC is one of the pulmonary function indicators; FVC values in patients with IPF tend to decrease.
Change in FVC from baseline (mL)
FVC is one of the pulmonary function indicators; FVC values in patients with IPF tend to decrease.
Change in FVCpp from baseline
Proportion of participants with an absolute decrease in FVCpp >10% from baseline
Proportion of participants with no decrease in FVCpp from baseline
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