Metabolic Dysfunction-Associated SteatohepatitisPhase 1NCT07334080
ECC4703 Food Effect and Relative Bioavailability Study in Healthy Adult Participants
A Phase 1 study testing ECC4703 F0 formulation, ECC4703 F1 formulation and ECC4703 F2 formulation in people with Metabolic Dysfunction-Associated Steatohepatitis, run by Eccogene at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatohepatitis
- What is being tested?
- ECC4703 F0 formulation, ECC4703 F1 formulation and ECC4703 F2 formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Jan 2026to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
Facility manager
About this study
Official title: 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.
Read the 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.
- Being tested
- ECC4703 F0 formulation, ECC4703 F1 formulation, ECC4703 F2 formulation, ECC4703 F3 formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECC4703 F0 formulationDrug
A single dose of ECC4703 F0
ECC4703 F1 formulationDrug
A single dose of ECC4703 F1
ECC4703 F2 formulationDrug
A single dose of ECC4703 F2
ECC4703 F3 formulationDrug
A single dose of ECC4703 F3
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: ECC4703 F0 formulation; Drug: ECC4703 F1 formulation; Drug: ECC4703 F2 formulation; Drug: ECC4703 F3 formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECC4703 pharmacokinetic (PK) parameters AUC0-tlast
Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non-Zero Concentration
Measured: Up to Day 13
ECC4703 PK parameters AUC0-inf
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
Measured: Up to Day 13
ECC4703 PK parameters Cmax
Maximum observed plasma concentration
Measured: Up to Day 13
ECC4703 PK parameters tmax
Time of the maximum observed plasma concentration
Measured: Up to Day 13
ECC4703 PK parameters AUC0-t
Area under the plasma concentration-time curve up to the last measurable concentration
Measured: Up to Day 13
ECC4703 PK parameters AUC0-24
Area under the plasma concentration-time curve from time 0 to 24 hours post-dose
Measured: 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
Measured: Up to Day 13
ECC4703 PK parameters tlag
lag time (time delay between dosing and first observed plasma concentration)
Measured: Up to Day 13
ECC4703 PK parameters t1/2
elimination half-life
Measured: Up to Day 13
ECC4703 PK parameters CL/F
apparent clearance
Measured: 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
Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination
Measured: Up to Day 18
ECC4703 PK parameters AUC0-t
area under the plasma concentration-time curve up to the last measurable concentration
Measured: Up to Day 13
ECC4703 PK parameters AUC0-24
Area under the plasma concentration-time curve from time 0 to 24 hours post-dose
Measured: 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
Measured: Up to Day 13
ECC4703 PK parameters tlag
lag time (time delay between dosing and first observed plasma concentration)
Measured: Up to Day 13
ECC4703 PK parameters t1/2
elimination half-life
Measured: Up to Day 13
ECC4703 PK parameters CL/F
apparent clearance
Measured: Up to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start7 Jan 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eccogene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eccogene Clinical Trials, Study director, Eccogene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334080
- Sponsor's protocol ID
- EC0008
- Status last verified
- Sep 2026
- First submitted
- 30 Dec 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07334080
- Acronym / sponsor ID
- EC0008
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- EccogeneIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ECC4703 F1 formulation | Experimental | Drug: ECC4703 F1 formulationParticipants 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 |
| ECC4703 F2 formulation | Experimental | Drug: ECC4703 F2 formulationParticipants 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 |
| ECC4703 F3 formulation | Experimental | Drug: ECC4703 F3 formulationParticipants 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 |
| ECC4703 F0 formulation | Experimental | Drug: ECC4703 F0 formulation, Drug: ECC4703 F1 formulation, Drug: ECC4703 F2 formulation, Drug: ECC4703 F3 formulationParticipants will receive a single dose of ECC4703 F0 fasted state, followed by ECC4703 F1, F2 or F3 fasted in subsequent treatment periods |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECC4703 F0 formulationA single dose of ECC4703 F0 | Drug | ECC4703 F0 formulation |
| ECC4703 F1 formulationA single dose of ECC4703 F1 | Drug | ECC4703 F0 formulation, ECC4703 F1 formulation |
| ECC4703 F2 formulationA single dose of ECC4703 F2 | Drug | ECC4703 F0 formulation, ECC4703 F2 formulation |
| ECC4703 F3 formulationA single dose of ECC4703 F3 | Drug | ECC4703 F0 formulation, ECC4703 F3 formulation |
Primary outcome
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
ECC4703 PK parameters AUC0-inf
Time frame: Up to Day 13
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
ECC4703 PK parameters Cmax
Time frame: Up to Day 13
Maximum observed plasma concentration
ECC4703 PK parameters tmax
Time frame: Up to Day 13
Time of the maximum observed plasma concentration
ECC4703 PK parameters AUC0-t
Time frame: Up to Day 13
Area under the plasma concentration-time curve up to the last measurable concentration
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
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
ECC4703 PK parameters tlag
Time frame: Up to Day 13
lag time (time delay between dosing and first observed plasma concentration)
ECC4703 PK parameters t1/2
Time frame: Up to Day 13
elimination half-life
ECC4703 PK parameters CL/F
Time frame: Up to Day 13
apparent clearance
7 secondary outcomes
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
ECC4703 PK parameters AUC0-t
Time frame: Up to Day 13
ECC4703 PK parameters AUC0-24
Time frame: Up to Day 13
ECC4703 PK parameters AUCextr
Time frame: Up to Day 13
ECC4703 PK parameters tlag
Time frame: Up to Day 13
ECC4703 PK parameters t1/2
Time frame: Up to Day 13
ECC4703 PK parameters CL/F
Time frame: Up to Day 13
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eccogene Clinical Trials study director
Eccogene
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ECC4703 F0 formulation, ECC4703 F1 formulation and ECC4703 F2 formulation in people with Metabolic Dysfunction-Associated Steatohepatitis, run by Eccogene at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eccogene Clinical Trials (86-21-61053022, contact@eccogene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECC4703 pharmacokinetic (PK) parameters AUC0-tlast (time frame: Up to Day 13). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.