Phase ll Study of HEC585 in Patients With IPF

Prior treatment

• In the opinion of the Investigator, subjects underwent significant deterioration in IPF within one month before randomization;
• Expected to receive lung transplantation during the study;
• History of unstable or worsening heart disease within 6 months before screening;
• Participated in other clinical study and received the last dose within 3 months before screening;
• History of smoking within 3 months before screening or are unwilling to quit smoking during the study;
• Subjects often drink alcohol within 6 months before the screening (drink more than 21 units of alcohol a week), or refuse to reduce alcohol intake during the study;
• History of drug abuse within 6 months before the screening;
• Subjects have received any of the following treatments within 28 days before randomization:
  • Any cytotoxic drug or immunosuppressant
  • Therapeutic drugs for IPF, including but not limited to pirfenidone, nintedanib, prednisone at \> 15 mg/d or other glucocorticoids of the equivalent dose, N-acetylcysteine at \> 600 mg/d.
  • Moderate and strong inhibitor or strong inducer of CYP1A2.
  • Strong inducers or strong CYP3A4 inhibitors.

Other illness

• Interstitial lung disease caused by other known causes;
• Any bacterial, viral, parasitic or fungal infection that needs to be treated at screening;
• History of tumors within 5 years before screening (except for localized cancers such as basal cell carcinoma);
• Moderate to severe hepatic insufficiency (Child-Pugh grade B or C, see Appendix 4);
• Allergic to any component of HEC585 Tablets or pirfenidone tablets;
• Any condition that, in the opinion of the investigator, would compromise the safety or compliance of the subject, or prevent the subject from completing the study.
• Human immunodeficiency virus (HIV) antibody is positive;
• Uncontrolled hepatitis B virus infection or hepatitis C virus infection;

Lab values

• Family or personal history of QT prolongation syndrome;
• TBil \> 1.5 × ULN or AST or ALT \> 2 × ULN;

Other

• Expected survival is less than 6 months;
• Cannot perform 6MWT or PFT;
• Pregnant or breastfeeding;
• CLcr \< 50 mL/min;
• QTcF \> 480 ms.

• Volunteer to participate in this clinical study and sign the ICF before the study begins;
• Aged 40-80 (including 40 and 80) ;
• Female or male subjects with child-bearing potential who agree and promise to take effective contraceptive measures;
• Diagnosed with IPF according to the Official ATS/ERS/JRS/ALAT Clinical Practice Guideline for IPF Diagnosis (2018);
• FEV1/FVC ≥ 0.7;
• FVC ≥ 45% predicted;
• DLCO corrected for Haemoglobin (Hb) ≥ 30% predicted of normal;
• In the opinion of the Investigator, subjects are willing and able to comply with the protocol requirements and attend the visit.