This study is open to adults with idiopathic pulmonary fibrosis who are at least 40 years old. The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.
IPF based on 2022 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest HRCT scan taken before or during screening period and if available surgical lung biopsy.
Usual interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by the investigator prior to screening. if indeterminate HRCT finding IPF may be confirmed locally by (historical) biopsy.
not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to screening and during the screening period, and not planning to start or restart anti fibrotic therapy.
on stable therapy with nintedanib or pirfenidone or nerandomilast for at least 12 weeks prior to screening and during the screening period.
Clinically significant airways obstruction (Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) < 0.7) at screening.
In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
Acute IPF exacerbation within 3 months prior to screening and/or during the screening period (investigator-determined).
History of persistent or active micturition/defecation syncope, known prior history of syncope, or concomitant other diseases increasing the risk of syncope (e.g., symptomatic bradycardia, second- or third-degree atrioventricular block, symptomatic valvular heart disease, etc.).
Parallel
HSK50042 dose 1
DrugHSK50042 taken orally once daily in the morning for 26 weeks.
HSK50042 dose 2
DrugHSK50042 taken orally once daily in the morning for 26 weeks.
HSK50042 dose 3
DrugHSK50042 taken orally once daily in the morning for 26 weeks.
Placebo
DrugPlacebo matching HSK50042 taken orally once daily in the morning for 26 weeks.
The change from baseline in forced vital capacity (FVC) at week 12
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness
The change from baseline in forced vital capacity (FVC) at week 26
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness
The change from baseline in percentage predicted forced vital capacity ( ppFVC) at week 12/26
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness
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