A Multicenter, Parallel, Randomized, Placebo (Double-blind) and Pirfenidone (Open-label) Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HEC585 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)
A multicenter, parallel, randomized, placebo (double-blind) and pirfenidone (open-label) controlled Phase III clinical trial to evaluate the efficacy and safety of HEC585 in patients with idiopathic pulmonary fibrosis (IPF)
• Voluntarily participate in this clinical study and sign the informed consent form before the study begins;
• When signing the informed consent form, the age should be between 40 and 80 years old (inclusive of 40 and 80), and gender is not restricted;
• Be diagnosed with IPF according to the diagnostic criteria of the IPF clinical practice guidelines jointly released by the American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society and the Latin American Thoracic Society in 2022 ; Chest high-resolution computed tomography (HRCT) examination (HRCT examination within 3 months before screening) or lung biopsy (if any) should be confirmed by central reading;
• The ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) at the screening period is ≥ 0.7;
• The percentage of FVC as a percentage of the normal predicted value at the screening period is ≥ 45%;
• The percentage of DLco (hemoglobin \[Hb\] corrected) as a percentage of the normal predicted value at the screening period is ≥ 30%;
• Female or male subjects with potential fertility agree and commit to taking effective contraceptive measures from the time of signing the informed consent form until 30 days after the last administration of the investigational drug; at the same time, avoid sperm/egg collection, sperm/egg donation;
• According to the assessment by the investigator, the subjects are willing and able to comply with the requirements of the protocol and attend the visits.