Phase 1 Study of ECC4703 With Sulfasalazine and Pitavastatin

A Phase 1, Open-Label, Fixed-Sequence, Single-Center, Two-Period, Drug-Drug Interaction Trial in Healthy Adult Participants to Evaluate the Effect of Steady-State ECC4703 on the Pharmacokinetics of Sulfasalazine (BCRP Probe Substrate) and Pitavastatin (OATP1B1/OATP1B3 Probe Substrate)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dyslipidaemia; Non-alcoholic Fatty Liver Disease (NAFLD)
• Intervention / Treatment: Drug: ECC4703; Drug: Sulfasalazine; Drug: Pitavastatin

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Eccogene Clinical Trials; Phone Number: 86-21-61053022; Email: contact@eccogene.com

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network Pty Ltd
      • Contact: Dr Ofer Gonen; Phone Number: +61 0431 614 515; Email: o.gonen@nucleusnetwork.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 comply with the trial requirements.
• Has a personal or family history of hereditary muscular disorders, previous statin-induced myopathy/rhabdomyolysis, or unexplained repeated or severe muscle pain.
• Has a history of any unexplained chronic skin rash or autoimmune skin diseases.
• Has a personal or family history of Stevens-Johnson syndrome (SJS), or other severe drug-induced skin reactions.
• History of surgery or hospitalisation within 3 months prior to screening, or surgery planned during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 - ECC4703 and Sulfasalazine; Cohort 1 participants will receive ECC4703 and sulfasalazine.	Drug: ECC4703; ECC4703 will be administered orally.; Drug: Sulfasalazine; Sulfasalazine will be administered orally.
Experimental: Cohort 2 - ECC4703 and Pitavastatin; Cohort 2 participants will receive ECC4703 and pitavastatin.	Drug: ECC4703; ECC4703 will be administered orally.; Drug: Pitavastatin; Pitavastatin will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sulfasalazine levels in the blood of participants who have taken ECC4703 (also called pharmacokinetic or 'PK' testing)	Pharmacokinetic (PK) endpoints include (but are not limited to) maximum plasma concentration, time to maximum plasma concentration, area under the drug concentration-time curve, and clearance of the drug will be measured as a composite outcome.	Blood samples for PK testing of sulfasalazine will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12
Change in pitavastatin levels in the blood of participants who have taken ECC4703 (also called pharmacokinetic or 'PK' testing)	Pharmacokinetic (PK) endpoints include (but are not limited to) maximum plasma concentration, time to maximum plasma concentration, area under the drug concentration-time curve, and clearance of the drug will be measured as a composite outcome.	Blood samples for PK testing of pitavastatin will be collected on Days 1, 2, 3, 4, 9, 10, 11 and 12.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse Events (AEs), as assessed by a 5-point scale, CTCAE v5.0	Adverse event monitoring includes measuring the frequency, severity and relationship of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) leading to treatment or study discontinuation. Severity of adverse events will be characterised from 1 (mild) to 5 (death).	From baseline to follow-up visit (on Day 19).
Change from Baseline in blood pressure, measured using a sphygmomanometer via a cuff on the arm		From baseline to follow-up visit (on Day 19).
Change from Baseline in heart rate, measured in beats-per-minute by a vital signs machine		From Baseline to follow-up visit (on Day 19).
Change from Baseline in respiratory rate, measured in breaths-per-minute manually via a 60-second count		From Baseline to follow-up visit (on Day 19).
Change from Baseline in body temperature in degrees Celsius, measured using a thermometer		From Baseline to follow-up visit (on Day 19).
Changes from Baseline in Clinical Laboratory Parameters including, but not limited to, haematology and blood chemistry.	Blood samples will be collected. All safety laboratory assessments will be assessed by a certified local laboratory, using that laboratory's normal ranges. Any clinically significant changes will be recorded as Adverse Event (AE). The severity of each AE (and SAE or Serious Adverse Event) will be graded using a 5-point scale	From baseline to follow-up visit (on Day 19)

Collaborators and Investigators

• Sponsor: Eccogene

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: BCRP inhibitor; OATP inhibitor
• Additional Relevant MeSH Terms: Metabolic Diseases; Digestive System Diseases; Liver Diseases; Lipid Metabolism Disorders; Fatty Liver; Nutritional and Metabolic Diseases; Non-alcoholic Fatty Liver Disease; Dyslipidemias; Sulfur Compounds; Organic Chemicals; Amides; Sulfonamides; Sulfones; Sulfasalazine; pitavastatin
• Other Study ID Numbers: EC0012

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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No