New IPF drug interaction study completed in healthy volunteers
NCT ID NCT07588646
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how a new drug called HEC585 interacts with two existing medicines for idiopathic pulmonary fibrosis (IPF): pirfenidone and nintedanib. Thirty-three healthy adults took part to measure drug levels and safety. The goal was to see if combining these drugs causes any changes in how they work in the body.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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33 people
The number who actually took part.
- Started
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Jun 2021
- Finished
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Nov 2021
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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). Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Shanghai Xuhui Central Hospital
Shanghai, China
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Other studies related to the condition(s) this trial covers.
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