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New IPF pill enters mid-stage trial – could it slow lung decline?

NCT ID NCT05060822

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 270 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.