A Phase ll Study to evaluate the efficacy and safety of various doses of HEC585 Tablets in patients with idiopathic pulmonary fibrosis
Eligibility
Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Change from Baseline to Week 24 in %FVC compared with placebo — 24 Weeks change in %FVC, measured using Spirometer, from baseline to week 24
Trial sites (1)
Facility
City
Region
Status
China-Japan Friendship Hospital
Beijing
Beijing Municipality
More Sunshine Lake Pharma Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.