Idiopathic Pulmonary FibrosisPhase 2NCT05060822
Phase ll Study of HEC585 in Patients With IPF
A Phase 2 study testing HEC585 and Pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
A Phase ll Study to evaluate the efficacy and safety of various doses of HEC585 Tablets in patients with idiopathic pulmonary fibrosis Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- 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
- 270 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2021to 11 Dec 2026
- Phase
- Phase 2
- 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
- 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.
Who cannot join
- 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);
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- 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:
- Any cytotoxic drug or immunosuppressant
- 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.
- Moderate and strong inhibitor or strong inducer of CYP1A2.
- Strong inducers or strong CYP3A4 inhibitors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Multi-center, Randomized, Placebo-controlled (Double-blind Design), Active Comparator-controlled (Open-label Design), Parallel-group, Dose-finding Study, to Evaluate the Efficacy and Safety of HEC585 Tablets in Patients With IPF
A Phase ll Study to evaluate the efficacy and safety of various doses of HEC585 Tablets in patients with idiopathic pulmonary fibrosis
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- HEC585, Pirfenidone, Placebo
- 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 Tablets，once daily
PirfenidoneDrug
Pirfenidone，three times a day
PlaceboDrug
Placebo，once daily
| Study group | Role | What they receive |
|---|---|---|
| HEC585 dose A | Experimental | Drug: HEC585 dose A once daily, up to 24 weeks-120 weeks Receives: Drug: HEC585 |
| HEC585 dose B | Experimental | Drug: HEC585 dose B once daily, up to 24 weeks-120 weeks Receives: Drug: HEC585 |
| HEC585 dose C | Experimental | Drug: HEC585 dose C once daily, up to 24 weeks-120 weeks Receives: Drug: HEC585 |
| pirfenidone | Active comparator | Drug: pirfenidone three times a day (target dose), up to 24 weeks Receives: Drug: Pirfenidone |
| placebo | Placebo comparator | Drug: placebo once daily, up to 24 weeks-120 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 24 in %FVC compared with placebo
change in %FVC, measured using Spirometer, from baseline to week 24
Measured: 24 Weeks
Secondary outcomes (10)
Change from Baseline to Week 24 in %FVC compared with Pirfenidone
change in %FVC, measured using Spirometer, from baseline to week 24
Measured: 24 Weeks
Change from Baseline to Week 12 in %FVC compared with placebo/ Pirfenidone
change in %FVC, measured using Spirometer, from baseline to week 12
Measured: 12 Weeks
Proportion of subjects with an absolute decline from baseline in FVC (% predicted) of > 10%
The proportion of subjects whose %FVC decline from baseline by more than 10% in each treatment group at W24
Measured: 24 Weeks
Time to first acute IPF exacerbation
Measured: 24 Weeks
All-cause mortality
Measured: 24 Weeks
IPF related mortality
Measured: 24 Weeks
Changes of 6MWT results
Measured: 12 Weeks, 24 Weeks
Changes of SGRQ scores
Measured: 12 Weeks, 24 Weeks
Changes of DLco (Hb correction)
Measured: 12 Weeks, 24 Weeks
Changes of resting SpO2
Measured: 12 Weeks, 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start30 Jun 2021
- Primary completion16 Jul 2025
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 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
- NCT05060822
- Sponsor's protocol ID
- HEC585-P-03
- Status last verified
- Apr 2026
- First submitted
- 18 Sep 2021
- 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 Phase II, Multi-center, Randomized, Placebo-controlled (Double-blind Design), Active Comparator-controlled (Open-label Design), Parallel-group, Dose-finding Study, to Evaluate the Efficacy and Safety of HEC585 Tablets in Patients With IPF
- ClinicalTrials.gov ID
- NCT05060822
- Acronym / sponsor ID
- HEC585-P-03
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 29 Sep 2021 (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 Phase ll Study to evaluate the efficacy and safety of various doses of HEC585 Tablets in patients with idiopathic pulmonary fibrosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HEC585 dose A | Experimental | Drug: HEC585Drug: HEC585 dose A once daily, up to 24 weeks-120 weeks |
| HEC585 dose B | Experimental | Drug: HEC585Drug: HEC585 dose B once daily, up to 24 weeks-120 weeks |
| HEC585 dose C | Experimental | Drug: HEC585Drug: HEC585 dose C once daily, up to 24 weeks-120 weeks |
| pirfenidone | Active comparator | Drug: PirfenidoneDrug: pirfenidone three times a day (target dose), up to 24 weeks |
| placebo | Placebo comparator | Drug: PlaceboDrug: placebo once daily, up to 24 weeks-120 weeks |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (27 listed)
- 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;
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 Tablets，once daily | Drug | HEC585 dose A, HEC585 dose B, HEC585 dose C |
| PirfenidonePirfenidone，three times a day | Drug | pirfenidone |
| PlaceboPlacebo，once daily | Drug | placebo |
Primary outcome
Change from Baseline to Week 24 in %FVC compared with placebo
Time frame: 24 Weeks
change in %FVC, measured using Spirometer, from baseline to week 24
10 secondary outcomes
Change from Baseline to Week 24 in %FVC compared with Pirfenidone
Time frame: 24 Weeks
Change from Baseline to Week 12 in %FVC compared with placebo/ Pirfenidone
Time frame: 12 Weeks
Proportion of subjects with an absolute decline from baseline in FVC (% predicted) of > 10%
Time frame: 24 Weeks
Time to first acute IPF exacerbation
Time frame: 24 Weeks
All-cause mortality
Time frame: 24 Weeks
IPF related mortality
Time frame: 24 Weeks
Changes of 6MWT results
Time frame: 12 Weeks, 24 Weeks
Changes of SGRQ scores
Time frame: 12 Weeks, 24 Weeks
Changes of DLco (Hb correction)
Time frame: 12 Weeks, 24 Weeks
Changes of resting SpO2
Time frame: 12 Weeks, 24 Weeks
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HEC585 and Pirfenidone in people with Idiopathic Pulmonary Fibrosis, 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 27 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: under way, not looking for participants, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 24 in %FVC compared with placebo (time frame: 24 Weeks). 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.