Idiopathic Pulmonary Fibrosis (IPF)Phase 3NCT07082842
Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF
A Phase 3 study testing HEC585 and Pirfenidone in people with Idiopathic Pulmonary Fibrosis (IPF), run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- HEC585 and Pirfenidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 472 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2025to 15 Feb 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in this clinical study and sign the informed consent form before the study begins;
- 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;
- 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;
- The ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) at the screening period is ≥ 0.7;
- The percentage of FVC as a percentage of the normal predicted value at the screening period is ≥ 45%;
- The percentage of DLco (hemoglobin [Hb] corrected) as a percentage of the normal predicted value at the screening period is ≥ 30%;
- 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;
- 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 cannot join
- The researchers believe that the subjects experienced significant deterioration of IPF within the first three months of the randomization period.
- Other known causes of interstitial lung disease, such as exposure to the home or occupational environment, connective tissue diseases, drug toxicity, etc.
- Abnormalities in the lungs or chest that are clinically significant and judged by the researchers to potentially affect the trial results.
- 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).
- Expected to undergo lung transplantation during the course of the study.
- Expected survival period less than 6 months.
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- History of malignant tumors within the previous 5 years (excluding localized cancers such as basal cell carcinoma).
- Moderate to severe liver dysfunction (Child-Pugh classification of grade B or C).
- Within six months before screening, history of unstable or deteriorating heart disease, including but not limited to the following conditions:
- Unstable angina pectoris;
- Myocardial infarction;
- Congestive heart failure requiring hospitalization or NYHA III/IV grade;
- Uncontrolled severe arrhythmia.
- Unable to perform the 6MWT or pulmonary function test, such as if the patient is mentally unstable and unable to cooperate, etc.;
- 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;
- The last administration of the study drug for other clinical trials occurred within 4 weeks before randomization or 5 half-lives (whichever is longer);
- Pregnant or breastfeeding;
- Within 3 months before screening, had a smoking history or was unwilling to maintain a smoking-free status during the study;
- 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)];
- Had a history of drug abuse within 6 months before screening;
- Has a family or personal history of long QT interval syndrome;
- 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.
- 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;
- During the screening period, glomerular filtration rate < 45 mL/min/1.73 m2, calculated using the CKD-EPI (based on serum creatinine) formula ;
- At the time of screening, human immunodeficiency virus antibody or syphilis spirochete antibody test results were positive;
- 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);
- During the screening period, QTcF > 480 ms (using the Fridericia formula, QTcF = QT/RR^0.33).
- Those who have previously taken isoniazidine hydrochloride;
- Within the first 4 weeks before randomization, used any of the following treatments:
- Any cytotoxic drugs or immunosuppressants, including but not limited to azathioprine, cyclophosphamide, methotrexate, cyclosporine, etc.;
- Pirfenidone or nintedanib;
- > 15 mg/d prednisone or equivalent dose of other glucocorticoids;
- Strong inducers or inhibitors of CYP3A4, CYP2C8 or CYP2C19 (including but not limited to ritonavir, clarithromycin, aletris, carbamazepine, gemfibrozil, fluoxetine, fluvoxamine, etc.);
- Moderate, strong inhibitors or inducers of CYP1A2 (including but not limited to fluvoxamine, ciprofloxacin, enoxacin, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
huaping Dai, PhD, 86-010-84206271, daihuaping@ccmu.edu.cn
About this study
Official title: 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)
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)
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- HEC585, Placebo, Pirfenidone
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC585Drug
HEC585 tablet, taken once daily
PlaceboDrug
HEC585 Simulation Board, taken once daily
PirfenidoneDrug
Pirfenidone, taken three times a day
| Study group | Role | What they receive |
|---|---|---|
| HEC585 | Experimental | Not described Receives: Drug: HEC585 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| pirfenidone | Active comparator | Not described Receives: Drug: Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FVC from baseline at 52 weeks (mL)
Measured: 52week
Secondary outcomes (5)
The interval (in days) from the start of the study until the first occurrence of any of the following clinical events (whichever occurs first) within 52 weeks
Measured: 52week
The percentage of FVC relative to the predicted value (%FVC) compared to the baseline value changes
Measured: 52week
The percentage of DLco(Hb-correction) relative to the expected value [%DLco(Hb-correction)] and the change from the baseline value
Measured: 52week
The total walking distance of 6MWT（six minutes walk ）test compared to the baseline value
The longer the 6MWT distance is, the better the patient's disease condition is.
Measured: 52week
The change in SGRQ（St George's Respiratory Questionnaire） score compared to the baseline
A lower SGRQ score indicates a better disease condition for the subject.
Measured: 52week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start27 Oct 2025
- Primary completion15 Jan 2031 (estimated)
- Study completion15 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082842
- Sponsor's protocol ID
- HEC585-IPF-301
- Status last verified
- Apr 2026
- First submitted
- 2 Jul 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07082842
- Acronym / sponsor ID
- HEC585-IPF-301
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 472 participants (estimated)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 15 Jan 2031 (estimated)
- Study completion
- 15 Feb 2032 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HEC585 | Experimental | Drug: HEC585 |
| Placebo | Placebo comparator | Drug: Placebo |
| pirfenidone | Active comparator | Drug: Pirfenidone |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily participate in this clinical study and sign the informed consent form before the study begins;
- 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;
- 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;
- The ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) at the screening period is ≥ 0.7;
- The percentage of FVC as a percentage of the normal predicted value at the screening period is ≥ 45%;
Key exclusion criteria (34 listed)
- The researchers believe that the subjects experienced significant deterioration of IPF within the first three months of the randomization period.
- Other known causes of interstitial lung disease, such as exposure to the home or occupational environment, connective tissue diseases, drug toxicity, etc.
- Abnormalities in the lungs or chest that are clinically significant and judged by the researchers to potentially affect the trial results.
- 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).
- Expected to undergo lung transplantation during the course of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEC585HEC585 tablet, taken once daily | Drug | HEC585 |
| PlaceboHEC585 Simulation Board, taken once daily | Drug | Placebo |
| PirfenidonePirfenidone, taken three times a day | Drug | pirfenidone |
Primary outcome
Change in FVC from baseline at 52 weeks (mL)
Time frame: 52week
5 secondary outcomes
The interval (in days) from the start of the study until the first occurrence of any of the following clinical events (whichever occurs first) within 52 weeks
Time frame: 52week
The percentage of FVC relative to the predicted value (%FVC) compared to the baseline value changes
Time frame: 52week
The percentage of DLco(Hb-correction) relative to the expected value [%DLco(Hb-correction)] and the change from the baseline value
Time frame: 52week
The total walking distance of 6MWT（six minutes walk ）test compared to the baseline value
Time frame: 52week
The change in SGRQ（St George's Respiratory Questionnaire） score compared to the baseline
Time frame: 52week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HEC585 and Pirfenidone in people with Idiopathic Pulmonary Fibrosis (IPF), run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact huaping dai Doctor of Medicine(M.D.) (010-84206278, daihuaping@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FVC from baseline at 52 weeks (mL) (time frame: 52week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.