Healthy volunteers needed to test new fatty liver drug with and without food
NCT ID NCT07334080
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This early-stage study tests a new drug called ECC4703, being developed for a serious fatty liver condition (MASH). Researchers want to see how taking the drug with or without food changes the amount that gets into the blood. 72 healthy adults will receive a single dose of the drug in different forms, and their blood levels will be measured over time. This study does not treat any disease; it simply gathers information to help design future trials.
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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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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- 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
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18 to 65 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: * Healthy male and female participants * Age of 18 to 65 years * BMI of 18.0 to 32.0 kg/m2 with a minimum body weight of 50.0 kg (110 lb) for males and 45.0 kg (99 lb) for females. * Female participants of childbearing potential must have negative serum pregnancy test at screening and a negative serum or urine pregnancy test prior to the first dose of study drug; use at least 1 highly effective method of contraception (e.g., hormonal contraception, intrauterine device, bilateral tubal occlusion, or vasectomized partner with confirmed success) during the study and for at least 90 days after the last dose of study drug; and refrain from egg donation or fertility treatments during the same period. * Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, or agree to practice true abstinence * Male participants agree to use contraception, or agree to practice true abstinence * Not taking any medication within 14 days (or at least 5 half-lives whichever is longer) prior to Day 1 dosing, with the exception of stable-dose contraception, stable-dose hormonal replacement therapy, paracetamol at up to 2 g/day; or other medication, which in the opinion of the investigator and sponsor will not interfere with study assessments. * No clinically significant findings in physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, clinical laboratory evaluations, concomitant medications, or medical/psychiatric history * Able to understand and sign and date informed consent Exclusion Criteria: * Females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 90 days after the study. * Concomitant participation in any investigational study of any nature * Blood loss of ≥470 mL for non-physiological reasons (i.e., trauma, blood collection, blood donation) within 3 months prior to the first dose of study drug, plasma donation within 2 weeks prior to the first dose, platelet donation within 6 weeks prior to the first dose, or plans to donate blood during this study or within 1 month after the last dose of study drug. * Clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systems * Significant allergic reaction to active ingredients or excipients of the study drug * Regularly uses tobacco or nicotine products, including e-cigarettes (\>5 times per week) or has stopped using regular tobacco or nicotine products within the past 2 months. * Unwilling to abstain from alcohol-containing products and/or xanthine/caffeine-containing products, including any food and beverages, within 48 hours prior to admission to the CRU on Day -1. * Unwilling to abstain from grapefruit, grapefruit juice, and Seville oranges from 7 days prior to check-in on Day -1 until after their final follow-up visit. * Unable to refrain from the use of any over-the-counter medications, prescription medications, nutritional supplements, or herbal medicines during the study, except for stable-dose contraception, stable-dose hormonal replacement therapy, paracetamol at up to 2 g/day; or other medication, which in the opinion of the investigator and sponsor will not interfere with study assessments. * Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol test, or medical history which in the opinion of the Investigator would prevent the participants from participating in the study. * Has had clinically significant interventional therapies and/or hospitalization (surgery, paracentesis, etc.) within 6 months prior to the study, or plans to have any surgeries during the duration of the study.
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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CMAX Clinical Research Pty Ltd
RECRUITINGAdelaide, South Australia, 5000, Australia
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Other studies related to the condition(s) this trial covers.
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- Could a weekly shot help more people donate part of their liver?
- Experimental drug aims to reverse liver scarring in MASH cirrhosis
- Experimental drug aims to stop liver failure in MASH cirrhosis