New IPF pill enters mid-stage trial – could it slow lung decline?
NCT ID NCT05060822
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental tablet called HEC585 in 270 adults with idiopathic pulmonary fibrosis (IPF), a disease that scars the lungs and makes breathing harder. Participants receive either HEC585, a placebo (dummy pill), or an active comparator (Pirfenidone) to see if HEC585 can improve lung function over 24 weeks. The goal is to find the right dose that slows disease progression with acceptable side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 270 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
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Other studies related to the condition(s) this trial covers.
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