Not Yet RecruitingPhase 1

Study of ECC4703 With Sulfasalazine and Pitavastatin

Australia40 participantsStarted 2026-07

Plain-language summary

Non-alcoholic fatty liver disease is a chronic, serious, life-threatening, inflammatory liver disease characterized by increased liver fat content, inflammation, and progressive fibrosis. The overall prevalence of non-alcoholic fatty liver disease is rapidly rising world-wide. ECC4703 is a potential new treatment for non-alcoholic fatty liver disease. The purpose of this research is to investigate the safety, tolerability and pharmacokinetics of sulfasalazine and pitavastatin when combined with ECC4703.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female between the ages of 18 and 65 years, inclusive, at the time of Screening. * Are healthy and in the opinion of the Investigator have an acceptable medical history (free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological, infective, or psychiatric diseases as determined by medical history over the past 5 years, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests). * Has not consumed and agrees to abstain from taking any prescription drugs or non-prescription drugs for 7 days or 5 half-lives (whichever is longer) prior to first dose of trial treatment and continuing through end of the Treatment Period. Exclusion Criteria: * Has a history of significant renal, hepatic, cardiovascular, psychiatric, neoplastic, thyroid disease/abnormality or other disease which, in the opinion of the Investigator, represents a safety risk for taking part in the trial. * Has a history of sensitivity to any of the trial treatments (and/or their excipients), or severe drug or other allergy * Has a history of drug abuse within the previous 2 years, or a positive drug screen at Screening and/or Day -1. * Regular consumption of more than 10 standard alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day * Has a history or current diagnosis of a significant psychiatric disorder that would, in the opinion of the Investigator, affect the participant's ability to compl…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 1 trial that's not yet recruiting — given that it's still in the very early stages of testing how ECC4703 interacts with sulfasalazine and pitavastatin in the body, what does that mean for what's currently known about its safety, and would waiting for results from a later-phase trial be worth discussing as an option?
2The trial seems focused on measuring how ECC4703 affects the blood levels of two existing drugs — sulfasalazine and pitavastatin — rather than directly treating my NAFLD or dyslipidaemia right now; could you help me understand what that means for my own treatment in the meantime?
3Since pitavastatin is a statin used for cholesterol, and I may have dyslipidaemia, is there a standard treatment path using existing approved medications I should consider first before exploring an early-phase study like this one?
4The trial is measuring how drugs are absorbed and cleared from the blood — if ECC4703 changes how pitavastatin or sulfasalazine behaves in my body, what kinds of side effects or drug interaction risks might that raise, and how would those be monitored if I were to participate?
5Because the trial hasn't started recruiting yet, how long might it realistically be before enrollment opens, and is there anything I should be doing to manage my NAFLD or dyslipidaemia while I wait to see if this becomes an option worth discussing further with you?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum plasma concentration of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)

Timeframe: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12

Time to maximum plasma concentration of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)

Timeframe: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12

Area under the drug concentration-time curve of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)

Timeframe: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12

Clearance of sulfasalazine in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)

Timeframe: Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12

Maximum plasma concentration of pitavastatin in the blood of participants who have taken ECC4703 (as part of called pharmacokinetic or 'PK' testing)

Timeframe: Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12

Trial details

NCT IDNCT07726368

SponsorEccogene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Eccogene Clinical Trials

86-21-61053022 contact@eccogene.com

View on ClinicalTrials.gov More Non-alcoholic Fatty Liver Disease (NAFLD) trials