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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF

A Multicenter, Parallel, Randomized, Placebo (Double-blind) and Pirfenidone (Open-label) Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HEC585 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF (NCT07082842) is a Phase 3 interventional studying Idiopathic Pulmonary Fibrosis (IPF), 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

A multicenter, parallel, randomized, placebo (double-blind) and pirfenidone (open-label) controlled Phase III clinical trial to evaluate the efficacy and safety of HEC585 in patients with idiopathic pulmonary fibrosis (IPF)

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Idiopathic Pulmonary Fibrosis (IPF), Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory 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.

A target enrollment of 472 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Voluntarily participate in this clinical study and sign the willing to sign a consent form form before the study begins; 2. When signing the willing to sign a consent form form, the age should be between 40 and 80 years old (inclusive of 40 and 80), and gender is not restricted; 3. Be diagnosed with IPF according to the diagnostic criteria of the IPF clinical practice guidelines jointly released by the American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society and the Latin American Thoracic Society in 2022 ; Chest high-resolution computed tomography (HRCT) examination (HRCT examination within 3 months before screening) or lung biopsy (if any) should be confirmed by central reading; 4. The ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) at the screening period is ≥ 0.7; 5. The percentage of FVC as a percentage of the normal predicted value at the screening period is ≥ 45%; 6. The percentage of DLco (hemoglobin \[Hb\] corrected) as a percentage of the normal predicted value at the screening period is ≥ 30%; 7. Female or male subjects with potential fertility agree and commit to taking effective contraceptive measures from the time of signing the willing to sign a consent form form until 30 days after the last administration of the investigational drug; at the same time, avoid sperm/egg collection, sperm/egg donation; 8. According to the assessment by the investigator, the subjects are willing and able to comply with the requirements of the protocol and attend the visits. Who Should NOT Join This Trial: 1. The researchers believe that the subjects experienced significant deterioration of IPF within the first three months of the randomization period. 2. Other known causes of interstitial lung disease, such as exposure to the home or occupational environment, connective tissue diseases, drug toxicity, etc. ...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. Voluntarily participate in this clinical study and sign the informed consent form before the study begins; 2. When signing the informed consent form, the age should be between 40 and 80 years old (inclusive of 40 and 80), and gender is not restricted; 3. Be diagnosed with IPF according to the diagnostic criteria of the IPF clinical practice guidelines jointly released by the American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society and the Latin American Thoracic Society in 2022 ; Chest high-resolution computed tomography (HRCT) examination (HRCT examination within 3 months before screening) or lung biopsy (if any) should be confirmed by central reading; 4. The ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) at the screening period is ≥ 0.7; 5. The percentage of FVC as a percentage of the normal predicted value at the screening period is ≥ 45%; 6. The percentage of DLco (hemoglobin \[Hb\] corrected) as a percentage of the normal predicted value at the screening period is ≥ 30%; 7. Female or male subjects with potential fertility agree and commit to taking effective contraceptive measures from the time of signing the informed consent form until 30 days after the last administration of the investigational drug; at the same time, avoid sperm/egg collection, sperm/egg donation; 8. According to the assessment by the investigator, the subjects are willing and able to comply with the requirements of the protocol and attend the visits. Exclusion Criteria: 1. The researchers believe that the subjects experienced significant deterioration of IPF within the first three months of the randomization period. 2. Other known causes of interstitial lung disease, such as exposure to the home or occupational environment, connective tissue diseases, drug toxicity, etc. 3. Abnormalities in the lungs or chest that are clinically significant and judged by the researchers to potentially affect the trial results. 4. Within one month before randomization, any active infection requiring systemic treatment (such as oral or intravenous administration) in the form of activity (including bacterial, viral, parasitic or fungal infections). 5. Expected to undergo lung transplantation during the course of the study. 6. Expected survival period less than 6 months. 7. History of malignant tumors within the previous 5 years (excluding localized cancers such as basal cell carcinoma). 8. Moderate to severe liver dysfunction (Child-Pugh classification of grade B or C). 9. Within six months before screening, history of unstable or deteriorating heart disease, including but not limited to the following conditions: 1. Unstable angina pectoris; 2. Myocardial infarction; 3. Congestive heart failure requiring hospitalization or NYHA III/IV grade; 4. Uncontrolled severe arrhythmia. 10. Unable to perform the 6MWT or pulmonary function test, such as if the patient is mentally unstable and unable to cooperate, etc.; 11. Allergic to any component of Ifinonate Hydrochloride Tablets (except the active ingredient, the excipients include microcrystalline cellulose, pre-gelatinized starch, cross-linked povidone, povidone, dibutyl hydroxytoluene, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide) or pirfenidone tablets; 12. The last administration of the study drug for other clinical trials occurred within 4 weeks before randomization or 5 half-lives (whichever is longer); 13. Pregnant or breastfeeding; 14. Within 3 months before screening, had a smoking history or was unwilling to maintain a smoking-free status during the study; 15. Within 6 months before screening, frequently drank alcohol \[average weekly alcohol consumption exceeding 21 units (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of 40% alcohol spirits)\]; 16. Had a history of drug abuse within 6 months before screening; 17. Has a family or personal history of long QT interval syndrome; 18. The investigator believes that the subject has conditions that may compromise their safety or compliance, significantly affect the pharmacokinetics of the drug, or prevent them from completing the study. 19. During the screening period, liver function test values exceeded any of the following standards: total bilirubin \> 1.5 times the upper limit of normal (ULN); aspartate aminotransferase or alanine aminotransferase \> 2 times ULN; 20. During the screening period, glomerular filtration rate \< 45 mL/min/1.73 m2, calculated using the CKD-EPI (based on serum creatinine) formula ; 21. At the time of screening, human immunodeficiency virus antibody or syphilis spirochete antibody test results were positive; 22. At the time of screening, there was an uncontrolled hepatitis B virus infection (positive hepatitis B surface antigen, and hepatitis B DNA ≥ 2x102 IU/mL) or hepatitis C virus infection (positive anti-hepatitis C antibody and hepatitis C RNA); 23. During the screening period, QTcF \> 480 ms (using the Fridericia formula, QTcF = QT/RR\^0.33). 24. Those who have previously taken isoniazidine hydrochloride; 25. Within the first 4 weeks before randomization, used any of the following treatments: 1. Any cytotoxic drugs or immunosuppressants, including but not limited to azathioprine, cyclophosphamide, methotrexate, cyclosporine, etc.; 2. Pirfenidone or nintedanib; 3. \> 15 mg/d prednisone or equivalent dose of other glucocorticoids; 4. Strong inducers or inhibitors of CYP3A4, CYP2C8 or CYP2C19 (including but not limited to ritonavir, clarithromycin, aletris, carbamazepine, gemfibrozil, fluoxetine, fluvoxamine, etc.); 5. Moderate, strong inhibitors or inducers of CYP1A2 (including but not limited to fluvoxamine, ciprofloxacin, enoxacin, etc.).

Treatments Being Tested

DRUG

HEC585

HEC585 tablet, taken once daily

DRUG

Placebo

HEC585 Simulation Board, taken once daily

DRUG

Pirfenidone

Pirfenidone, taken three times a day

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 (NCT07082842), 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 NCT07082842 clinical trial studying?

A multicenter, parallel, randomized, placebo (double-blind) and pirfenidone (open-label) controlled Phase III clinical trial to evaluate the efficacy and safety of HEC585 in patients with idiopathic pulmonary fibrosis (IPF) The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07082842?

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 NCT07082842?

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 NCT07082842. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07082842. 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 2026-05-08 · Data from ClinicalTrials.gov.