ECC4703 Food Effect and Relative Bioavailability Study in Healthy Adult Participants

January 14, 2026 updated by: Eccogene

A Phase I, Open-Label, Randomized, Single-Dose, Crossover Study to Evaluate Food Effect and Relative Bioavailability of ECC4703 Formulations (F0, F1, F2, and F3) in Healthy Adults

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Part 1 will include 3 cohorts of 16 participants each, completing 2 single-dose crossover periods to assess food effect on ECC4703 formulations (F1, F2, and F3). Part 2 of the study will enroll approximately 24 participants to compare selected formulations from Part 1 to formulation (F0), using an adaptive design to finalize sequence, treatment periods, and food conditions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • CMAX Clinical Research Pty Ltd
        • Contact:
          • Facility manager

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ECC4703 F1 formulation
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
A single dose of ECC4703 F1
Experimental: ECC4703 F2 formulation
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
A single dose of ECC4703 F2
Experimental: ECC4703 F3 formulation
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
A single dose of ECC4703 F3
Experimental: ECC4703 F0 formulation
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 F1 formulation
A single dose of ECC4703 F1
Drug: ECC4703 F2 formulation
A single dose of ECC4703 F2
Drug: ECC4703 F3 formulation
A single dose of ECC4703 F3
Drug: ECC4703 F0 formulation
A single dose of ECC4703 F0

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ECC4703 PK parameters AUC0-inf
Time Frame: Up to Day 13
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
Up to Day 13
ECC4703 PK parameters Cmax
Time Frame: Up to Day 13
Maximum observed plasma concentration
Up to Day 13
ECC4703 PK parameters tmax
Time Frame: Up to Day 13
Time of the maximum observed plasma concentration
Up to Day 13
ECC4703 PK parameters AUC0-t
Time Frame: Up to Day 13
Area under the plasma concentration-time curve up to the last measurable concentration
Up to Day 13
ECC4703 PK parameters AUC0-24
Time Frame: Up to Day 13
Area under the plasma concentration-time curve from time 0 to 24 hours post-dose
Up to Day 13
ECC4703 PK parameters AUCextr
Time Frame: Up to Day 13
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
Time Frame: Up to Day 13
lag time (time delay between dosing and first observed plasma concentration)
Up to Day 13
ECC4703 PK parameters t1/2
Time Frame: Up to Day 13
elimination half-life
Up to Day 13
ECC4703 PK parameters CL/F
Time Frame: Up to Day 13
apparent clearance
Up to Day 13
ECC4703 pharmacokinetic (PK) parameters AUC0-tlast
Time Frame: Up to Day 13
Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non-Zero Concentration
Up to Day 13

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ECC4703 PK parameters AUC0-24
Time Frame: Up to Day 13
Area under the plasma concentration-time curve from time 0 to 24 hours post-dose
Up to Day 13
ECC4703 PK parameters AUCextr
Time Frame: Up to Day 13
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
Time Frame: Up to Day 13
lag time (time delay between dosing and first observed plasma concentration)
Up to Day 13
ECC4703 PK parameters t1/2
Time Frame: Up to Day 13
elimination half-life
Up to Day 13
ECC4703 PK parameters CL/F
Time Frame: Up to Day 13
apparent clearance
Up to Day 13
Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
Time Frame: Up to Day 18
Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination
Up to Day 18
ECC4703 PK parameters AUC0-t
Time Frame: Up to Day 13
area under the plasma concentration-time curve up to the last measurable concentration
Up to Day 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eccogene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Eccogene Clinical Trials, Eccogene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EC0008

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

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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