Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study to Explore the Therapeutic Effect of HEC585 on Delaying Forced Vital Capacity (FVC) Decline and Tolerance in Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Patients

A Phase IIb, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HEC585 Tablets in Patients With Progressive Fibrosing Interstitial Lung Disease

A Study to Explore the Therapeutic Effect of HEC585 on Delaying Forced Vital Capacity (FVC) Decline and Tolerance in Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Patients (NCT05139719) is a Phase 2 interventional studying Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF), sponsored by Sunshine Lake Pharma Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The main goal of this phase llb study is to compare the efficacy and safety of two doses of HEC585 tablets with placebo which is a look-alike substance that contains no active drug in patients with progressive fibrosing interstitial lung diseases. This study is divided into two stages, i.e. main study stage with 24 weeks treatment duration followed by up to 96 weeks treatment extended study stage.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 110 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Volunteer to participate and sign the ICF. 2. Male or female patients' age ≥ 18 years when signing the ICF. 3. Patients with known or unknown etiology (except IPF) and clear pulmonary fibrosis on chest CT have undergone conventional clinical treatment (assessed by the investigator, including follow-up observation) for ≥ 3 months. At least two of the following criteria occurring within 12 months before screening without alternative explanation (such as infection, heart failure, etc.): i) Worsening respiratory symptoms like cough, shortness of breath. ii) Physiological evidence of disease progression (either of the following): 1. absolute FVC (% of predicted) decline ≥ 5%. 2. absolute DLco\[Hb corrected\] (% of predicted) decline ≥ 10%. iii) Radiological evidence of disease progression (one or more of the following): <!-- --> 1. Increased extent or severity of traction bronchiectasis and bronchiolectasis. 2. New ground-glass opacity with traction bronchiectasis. 3. New fine reticulation. 4. Increased extent or increased coarseness of reticular abnormality. 5. New or increased honeycombing. 6. Increased lobar volume loss. 4. Fibrosing lung disease on HRCT, defined as reticular abnormality with traction bronchiectasis with or without honeycombing, with disease extent of \>10% as confirmed by central readers. 5. For patients with underlying connective tissue disease (CTD) should be in the stable status which is defined by no initiation of new therapy, treatment dose adjustment or withdrawal of therapy within 12 weeks prior to randomization. 6. FEV1/FVC ≥ 0.7 before using bronchodilators. 7. %FVC ≥ 45% predicted. 8. Carbon Monoxide Diffusion Capacity (DLCO) corrected for Haemoglobin (Hb) ≥ 30% and ≤ 80% predicted of normal. 9. Fertile female or male subjects agreed and promised to take effective contraception measures from signing the ICF till 30 days after last administration. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Volunteer to participate and sign the ICF. 2. Male or female patients' age ≥ 18 years when signing the ICF. 3. Patients with known or unknown etiology (except IPF) and clear pulmonary fibrosis on chest CT have undergone conventional clinical treatment (assessed by the investigator, including follow-up observation) for ≥ 3 months. At least two of the following criteria occurring within 12 months before screening without alternative explanation (such as infection, heart failure, etc.): i) Worsening respiratory symptoms like cough, shortness of breath. ii) Physiological evidence of disease progression (either of the following): 1. absolute FVC (% of predicted) decline ≥ 5%. 2. absolute DLco\[Hb corrected\] (% of predicted) decline ≥ 10%. iii) Radiological evidence of disease progression (one or more of the following): <!-- --> 1. Increased extent or severity of traction bronchiectasis and bronchiolectasis. 2. New ground-glass opacity with traction bronchiectasis. 3. New fine reticulation. 4. Increased extent or increased coarseness of reticular abnormality. 5. New or increased honeycombing. 6. Increased lobar volume loss. 4. Fibrosing lung disease on HRCT, defined as reticular abnormality with traction bronchiectasis with or without honeycombing, with disease extent of \>10% as confirmed by central readers. 5. For patients with underlying connective tissue disease (CTD) should be in the stable status which is defined by no initiation of new therapy, treatment dose adjustment or withdrawal of therapy within 12 weeks prior to randomization. 6. FEV1/FVC ≥ 0.7 before using bronchodilators. 7. %FVC ≥ 45% predicted. 8. Carbon Monoxide Diffusion Capacity (DLCO) corrected for Haemoglobin (Hb) ≥ 30% and ≤ 80% predicted of normal. 9. Fertile female or male subjects agreed and promised to take effective contraception measures from signing the ICF till 30 days after last administration. 10. Subjects are willing and able to comply with the protocol requirements and attend visits assessed by the investigator. Exclusion Criteria: 1. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF). 2. Lung with other clinically significant abnormalities which the investigator assess to have an effect on the results of study. 3. Significant Pulmonary Arterial Hypertension (PAH), such as meeting the following: Previous clinical or echocardiographic evidence of significant right heart failure, History of right heart catheterization showing a cardiac index ≤ 2 L/min/m², or PAH requiring parenteral therapy with epoprostenol/treprostinil. 4. Major extrapulmonary physiological or pathological restriction (e.g. chest wall abnormality, large pleural effusion). 5. Expected to receive lung transplantation during the study. 6. Expected survival time is less than 6 months. 7. History of malignant tumors within 5 years (except for localized cancers such as basal cell carcinoma and carcinoma in situ of cervix). 8. Thyroid dysfunction that the investigator assessed to be clinically significant and needed to be treated. 9. History of unstable or worsening heart disease during the 6 months prior to screening, including but not limited to the following: 1. Unstable cardiac angina, 2. Acute Myocardial infarction, 3. Congestive heart failure (need to be treated in hospital or NYHA III/IV), 4. Uncontrolled Severe Arrhythmias. 10. TBIL \>1.2 × ULN, AST or ALT \> 1.5 × ULN. 11. CLcr \< 50 mL/min. 12. Human immunodeficiency virus (HIV) or treponema pallidum antibody is positive. 13. Uncontrolled hepatitis B virus infection or hepatitis C virus infection. 14. Use of any of the following medications for the treatment of Interstitial Lung Disease (ILD) or influence the effect or safety of investigational drug: 1. Strong inducers or strong inhibitors of CYP3A4 within 4 weeks before randomization. 2. Azathioprine (AZA), cyclosporine, MMF ( \> 1.5 g/d or equivalent dose), tripterygium glycosides , hydroxychloroquine, tacrolimus, prednisone \> 15mg/day or equivalent systemic glucocorticoid therapy, and the combination of OCS+AZA+NAC within 4 weeks before randomization. 3. Cyclophosphamide within 8 weeks before randomization. 4. Combination of ≤ 15mg/day or equivalent systemic glucocorticoid therapy with ≤ 1.5 g/d or equivalent dose MMF within 12 weeks before randomization. 5. Pirfenidone or nintedanib within 1 months before screening. 6. Rituximab, Adalimumab, Secukinumab, Infliximab, Tocilizumab, Certolizumab, Golimumab, Tofacitinib, Baricitinib, Etanercept, Abatacept within 6 months before randomization. 15. Subjects cannot complete the PFT、6MWT,or questionnaires. 16. Allergic to any component of HEC585 Tablets. 17. Participated in other clinical study and received the last dose within 3 months before screening. 18. Pregnant or breastfeeding. 19. History of smoking (≥ 10 cigarettes/day) within 3 months before screening or are unwilling to quit smoking during the study. 20. History of alcohol or drug abuse within 6 months before the screening. 21. 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.

Treatments Being Tested

DRUG

HEC585 dose A

taking HEC585 dose A orally once daily, up to 24 weeks in main stage (if applicable); up to 96 weeks in extended stage

DRUG

HEC585 dose B

taking HEC585 dose B orally once daily, up to 24 weeks in main stage; up to 96 weeks in extended stage

DRUG

Placebo

taking Placebo orally once daily, up to 24 weeks in main stage

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

China-Japan Friendship Hospital
Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05139719), the sponsor (Sunshine Lake Pharma Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05139719 clinical trial studying?

The main goal of this phase llb study is to compare the efficacy and safety of two doses of HEC585 tablets with placebo which is a look-alike substance that contains no active drug in patients with progressive fibrosing interstitial lung diseases. This study is divided into two stages, i.e. main study stage with 24 weeks treatment duration followed by up to 96 weeks treatment extended study stage. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05139719?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05139719?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05139719. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05139719. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.