Idiopathic Pulmonary FibrosisPhase 1NCT07588646
Study To Investigate The Potential DDI Between HEC585 And Pirfenidone/Nintedanib In Healthy Subjects
A Phase 1 study testing HEC585, Nintedanib and Pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and pirfenidone in healthy male and female subjects. A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and nintedanib in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- HEC585, Nintedanib and Pirfenidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2021to 30 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who are willing and are able to provide a written informed consent to participate in the study.
- Without Plann for pregnant or sperm/egg donation plan, and voluntary effective contraceptive measures during the trial period and within 3 months after the last dose.
- Subjects aged between 18 and 45 (both inclusive) years old.
- The first part of the study included male and female subjects, and the second part of the study included only male subjects.
- Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥19 and ≤28 kg/m2 at screening.
- Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).
Who cannot join
- Subjects with a positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies and/or TP antibodies at screening.
- Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening; and/or with history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system (such as thymus disease), reproductive system (such as prostate, testis, epididymis, ovarian disease); and/or mental illness.
- Subjects with photosensitivity and/or other skin diseases.
- Subjects with Bleeding risk.
- Subjects with known allergic history or constitution to peanuts, soybeans, study drugs or any of their components.
- Take any prescription or non-prescription medications within 14 days prior to initial dosing, or take any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
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- Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
- Positive results from urine drug screen test.
- History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of > 21 units/week), or positive results from alcohol breath test.
- For the first part of the study, subjects who had positive urine cotinine test or had smoked within 1 month before administration; for the second part of the study, subjects who had smoked more than 10 cigarettes per day within 3 months before administration.
- Donate blood or lose blood 400 mL or more within 3 months prior to initial dosing.
- Subjects who plan to receive or have had organ transplants.
- Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
- Subjects who participated in the other clinical trial within 3 months prior to initial dosing.
- Others conditions that are not suitable for clinical trial participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label Study Designed to Assess the Drug-drug Interaction of HEC585 And Pirfenidone/Nintedanib In Healthy Subjects
A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and pirfenidone in healthy male and female subjects. A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and nintedanib in healthy male subjects.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- HEC585, Nintedanib, 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
DDI of HEC585 and Pirfenidone：HEC585, once daily，D5-D14 and D18-D27; DDI of HEC585 and Nintedanib：HEC585，once daily，D14-D23 and D27-D36
NintedanibDrug
DDI of HEC585 andNintedanib：Nintedanib，twice a day，D1-D7 and D30-D36
PirfenidoneDrug
DDI of HEC583 and Pirfenidone： Pirfenidone：three times a day，D1-D3 and D25-D27
| Study group | Role | What they receive |
|---|---|---|
| HEC585 and Pirfenidone | Experimental | The DDI study of HEC585 and Pirfenidone Receives: Drug: HEC585; Drug: Pirfenidone |
| HEC585 and Nintedanib | Experimental | The DDI study of HEC585 and Nintedanib Receives: Drug: HEC585; Drug: Nintedanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from 0 to 24 hours [AUC (0~24)]
Area under the curve from 0 to 24 hours under steady-state conditions for HEC585 and Pirfenidone
Measured: Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.
Maximum Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration under steady-state conditions for Pirfenidone and HEC585
Measured: Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.
Area under the curve from 0 to 24 hours [AUC (0~24)]
Area under the curve from 0 to 24 hours under steady-state conditions for HEC585 and Nintedanib
Measured: Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase.
Observed Plasma Concentration (Cmax)
Observed Plasma Concentration under steady-state conditions for HEC585 and Nintedanib
Measured: Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase.
Secondary outcomes (2)
Incidence of treatment-emergent adverse events (TEAEs）
Incidence of treatment-emergent adverse events (TEAEs）assessed by CTCAE V5.0
Measured: up to 31 days（HEC585 and Pirfenidone）
Incidence of treatment-emergent adverse events (TEAEs）
Incidence of treatment-emergent adverse events (TEAEs）assessed by CTCAE V5.0
Measured: up to 40 days（HEC585 and Nintedanib）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start29 Jun 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
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
- NCT07588646
- Sponsor's protocol ID
- HEC585-P-04/CRC-C2032
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 15 May 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label Study Designed to Assess the Drug-drug Interaction of HEC585 And Pirfenidone/Nintedanib In Healthy Subjects
- ClinicalTrials.gov ID
- NCT07588646
- Acronym / sponsor ID
- HEC585-P-04/CRC-C2032
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 15 May 2026 (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 single-center, open-label study designed to assess the drug-drug interaction of HEC585 and pirfenidone in healthy male and female subjects. A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and nintedanib in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEC585 and Pirfenidone | Experimental | Drug: HEC585, Drug: PirfenidoneThe DDI study of HEC585 and Pirfenidone |
| HEC585 and Nintedanib | Experimental | Drug: HEC585, Drug: NintedanibThe DDI study of HEC585 and Nintedanib |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects who are willing and are able to provide a written informed consent to participate in the study.
- Without Plann for pregnant or sperm/egg donation plan, and voluntary effective contraceptive measures during the trial period and within 3 months after the last dose.
- Subjects aged between 18 and 45 (both inclusive) years old.
- The first part of the study included male and female subjects, and the second part of the study included only male subjects.
- Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥19 and ≤28 kg/m2 at screening.
Key exclusion criteria (15 listed)
- Subjects with a positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies and/or TP antibodies at screening.
- Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening; and/or with history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system (such as thymus disease), reproductive system (such as prostate, testis, epididymis, ovarian disease); and/or mental illness.
- Subjects with photosensitivity and/or other skin diseases.
- Subjects with Bleeding risk.
- Subjects with known allergic history or constitution to peanuts, soybeans, study drugs or any of their components.
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 |
|---|---|---|
| HEC585DDI of HEC585 and Pirfenidone：HEC585, once daily，D5-D14 and D18-D27; DDI of HEC585 and Nintedanib：HEC585，once daily，D14-D23 and D27-D36 | Drug | HEC585 and Nintedanib, HEC585 and Pirfenidone |
| NintedanibDDI of HEC585 andNintedanib：Nintedanib，twice a day，D1-D7 and D30-D36 | Drug | HEC585 and Nintedanib |
| PirfenidoneDDI of HEC583 and Pirfenidone： Pirfenidone：three times a day，D1-D3 and D25-D27 | Drug | HEC585 and Pirfenidone |
Primary outcome
Area under the curve from 0 to 24 hours [AUC (0~24)]
Time frame: Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.
Area under the curve from 0 to 24 hours under steady-state conditions for HEC585 and Pirfenidone
Maximum Plasma Concentration (Cmax)
Time frame: Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.
Maximum Observed Plasma Concentration under steady-state conditions for Pirfenidone and HEC585
Area under the curve from 0 to 24 hours [AUC (0~24)]
Time frame: Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase.
Area under the curve from 0 to 24 hours under steady-state conditions for HEC585 and Nintedanib
Observed Plasma Concentration (Cmax)
Time frame: Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase.
Observed Plasma Concentration under steady-state conditions for HEC585 and Nintedanib
2 secondary outcomes
Incidence of treatment-emergent adverse events (TEAEs）
Time frame: up to 31 days（HEC585 and Pirfenidone）
Incidence of treatment-emergent adverse events (TEAEs）
Time frame: up to 40 days（HEC585 and Nintedanib）
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 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 1 study testing HEC585, Nintedanib 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 6 inclusion and 15 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: finished, as of the sponsor's last update on 15 May 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the curve from 0 to 24 hours [AUC (0~24)] (time frame: Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.). The study lists 4 primary outcomes in all. 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 15 May 2026.