Phase ll Study of HEC585 in Patients With IPF

April 16, 2026 updated by: Sunshine Lake Pharma Co., Ltd.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • China-Japan Friendship Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: pirfenidone
Drug: pirfenidone three times a day (target dose), up to 24 weeks
Drug: Pirfenidone
Pirfenidone，three times a day
Experimental: HEC585 dose A
Drug: HEC585 dose A once daily, up to 24 weeks-120 weeks
Drug: HEC585
HEC585 Tablets，once daily
Experimental: HEC585 dose B
Drug: HEC585 dose B once daily, up to 24 weeks-120 weeks
Drug: HEC585
HEC585 Tablets，once daily
Experimental: HEC585 dose C
Drug: HEC585 dose C once daily, up to 24 weeks-120 weeks
Drug: HEC585
HEC585 Tablets，once daily
Placebo Comparator: placebo
Drug: placebo once daily, up to 24 weeks-120 weeks
Drug: Placebo
Placebo，once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
24 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline to Week 24 in %FVC compared with Pirfenidone
Time Frame: 24 Weeks
change in %FVC, measured using Spirometer, from baseline to week 24
24 Weeks
Change from Baseline to Week 12 in %FVC compared with placebo/ Pirfenidone
Time Frame: 12 Weeks
change in %FVC, measured using Spirometer, from baseline to week 12
12 Weeks
Proportion of subjects with an absolute decline from baseline in FVC (% predicted) of > 10%
Time Frame: 24 Weeks
The proportion of subjects whose %FVC decline from baseline by more than 10% in each treatment group at W24
24 Weeks
Time to first acute IPF exacerbation
Time Frame: 24 Weeks
24 Weeks
All-cause mortality
Time Frame: 24 Weeks
24 Weeks
IPF related mortality
Time Frame: 24 Weeks
24 Weeks
Changes of 6MWT results
Time Frame: 12 Weeks, 24 Weeks
12 Weeks, 24 Weeks
Changes of SGRQ scores
Time Frame: 12 Weeks, 24 Weeks
12 Weeks, 24 Weeks
Changes of DLco (Hb correction)
Time Frame: 12 Weeks, 24 Weeks
12 Weeks, 24 Weeks
Changes of resting SpO2
Time Frame: 12 Weeks, 24 Weeks
12 Weeks, 24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunshine Lake Pharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 11, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HEC585-P-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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