ECC4703 Food Effect and Relative Bioavailability Study in Healthy Adult Participants

NCT07334080 | Recruiting Phase 1 FDA Drug

• 1 other identifier: EC0008
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, open-label, randomized, single-dose, 2-part study designed to evaluate the food effect and relative bioavailability of ECC4703 in healthy adult participants.

Conditions

Metabolic Dysfunction-Associated Steatohepatitis

Outcome Measures

Primary Outcomes (10)

• ECC4703 pharmacokinetic (PK) parameters AUC0-tlast

  Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non-Zero Concentration

  Up to Day 13

• ECC4703 PK parameters AUC0-inf

  Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity

  Up to Day 13

• ECC4703 PK parameters Cmax

  Maximum observed plasma concentration

  Up to Day 13

• ECC4703 PK parameters tmax

  Time of the maximum observed plasma concentration

  Up to Day 13

• ECC4703 PK parameters AUC0-t

  Area under the plasma concentration-time curve up to the last measurable concentration

  Up to Day 13

• ECC4703 PK parameters AUC0-24

  Area under the plasma concentration-time curve from time 0 to 24 hours post-dose

  Up to Day 13

• ECC4703 PK parameters AUCextr

  percentage of area under the concentration-time curve that is due to extrapolation from the last measurable concentration to infinity

  Up to Day 13

• ECC4703 PK parameters tlag

  lag time (time delay between dosing and first observed plasma concentration)

  Up to Day 13

• ECC4703 PK parameters t1/2

  elimination half-life

  Up to Day 13

• ECC4703 PK parameters CL/F

  apparent clearance

  Up to Day 13

Secondary Outcomes (7)

• Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations

  Up to Day 18

• ECC4703 PK parameters AUC0-t

  Up to Day 13

• ECC4703 PK parameters AUC0-24

  Up to Day 13

• ECC4703 PK parameters AUCextr

  Up to Day 13

• ECC4703 PK parameters tlag

  Up to Day 13

Study Arms (4)

ECC4703 F1 formulation

EXPERIMENTAL

Participants will receive a single dose of ECC4703 F1 high-fat or fasted state, followed by ECC4703 F1 fasted or high-fat state, respectively, in subsequent treatment periods

Drug: ECC4703 F1 formulation

ECC4703 F2 formulation

EXPERIMENTAL

Participants will receive a single dose of ECC4703 F2 high-fat or fasted state, followed by ECC4703 F2 fasted or high-fat state, respectively, in subsequent treatment periods

Drug: ECC4703 F2 formulation

ECC4703 F3 formulation

EXPERIMENTAL

Participants will receive a single dose of ECC4703 F3 high-fat or fasted state, followed by ECC4703 F3 fasted or high-fat state, respectively, in subsequent treatment periods

Drug: ECC4703 F3 formulation

ECC4703 F0 formulation

EXPERIMENTAL

Participants will receive a single dose of ECC4703 F0 fasted state, followed by ECC4703 F1, F2 or F3 fasted in subsequent treatment periods

Drug: ECC4703 F0 formulation; Drug: ECC4703 F1 formulation; Drug: ECC4703 F2 formulation; Drug: ECC4703 F3 formulation

Interventions

ECC4703 F1 formulation DRUG

A single dose of ECC4703 F1

ECC4703 F0 formulation; ECC4703 F1 formulation

ECC4703 F2 formulation DRUG

A single dose of ECC4703 F2

ECC4703 F0 formulation; ECC4703 F2 formulation

ECC4703 F3 formulation DRUG

A single dose of ECC4703 F3

ECC4703 F0 formulation; ECC4703 F3 formulation

ECC4703 F0 formulation DRUG

A single dose of ECC4703 F0

ECC4703 F0 formulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eccogene: lead

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

RECRUITING

Study Officials

• Eccogene Clinical Trials

  Eccogene

  STUDY DIRECTOR

Central Study Contacts

Eccogene Clinical Trials

CONTACT

86-21-61053022; contact@eccogene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: January 10, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)