Overview

Phase ll Study of HEC585 in Patients With IPF

Status:
Recruiting
Trial end date:
2023-05-11
Target enrollment:
0
Participant gender:
All
Summary
A Phase ll Study to evaluate the efficacy and safety of various doses of HEC585 Tablets in patients with idiopathic pulmonary fibrosis
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sunshine Lake Pharma Co., Ltd.
Treatments:
Pirfenidone
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- In the opinion of the Investigator, subjects underwent significant deterioration in
IPF within one month before randomization;

- Interstitial lung disease caused by other known causes;

- Any bacterial, viral, parasitic or fungal infection that needs to be treated at
screening;

- Expected to receive lung transplantation during the study;

- Expected survival is less than 6 months;

- 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);

- History of unstable or worsening heart disease within 6 months before screening;

- Cannot perform 6MWT or PFT;

- Allergic to any component of HEC585 Tablets or pirfenidone tablets;

- Participated in other clinical study and received the last dose within 3 months before
screening;

- Pregnant or breastfeeding;

- 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;

- Family or personal history of QT prolongation syndrome;

- 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.

- TBil > 1.5 × ULN or AST or ALT > 2 × ULN;

- CLcr < 50 mL/min;

- Human immunodeficiency virus (HIV) antibody is positive;

- Uncontrolled hepatitis B virus infection or hepatitis C virus infection;

- QTcF > 480 ms.

- Subjects have received any of the following treatments within 28 days before
randomization:

1. Any cytotoxic drug or immunosuppressant

2. 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.

3. Moderate and strong inhibitor or strong inducer of CYP1A2.

4. Strong inducers or strong CYP3A4 inhibitors.