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Nonalcoholic SteatohepatitisPhase 1NCT05012423

FTIH Study of ECC0509 in Healthy Volunteers

A Phase 1 study testing ECC0509 in people with Nonalcoholic Steatohepatitis and Osteoarthritis, run by Eccogene at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Dose, First-Time-In-Human Study to Assess The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ECC0509 in Healthy Volunteers. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Nonalcoholic Steatohepatitis, Osteoarthritis
What is being tested?
ECC0509
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
89 participants
Where
1 siteAustralia
Study dates
26 Jul 2021to 22 Jul 2023
Phase
Phase 1
Are there results?
None posted in the registry

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 or non-childbearing potential female
  • Age ≥18 and ≤65 years old
  • BMI ≥18.0 and ≤32.0 kg/m2
  • Male participants agree to use contraception
  • No clinically significant abnormal findings in physical examination, 12-lead electrocardiogram (ECG), laboratory tests, or medical history
  • Able to understand and sign informed consent

Who cannot join

  • Significant allergic reactions to any drug.
  • History of significant drug abuse or alcohol abuse within 1 year prior to screening
  • Concomitant participation in any investigational study of any nature
  • Use of any concomitant medication except for the occasional use of acetaminophen (up to 2 g daily)
  • Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
  • Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol breath test, or medical history which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • CMAX Clinical Research

    Adelaide, South Australia, 5000

Other trials in Australia

About this study

Official title: A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose, First-Time-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ecc0509 in Healthy Volunteers

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Dose, First-Time-In-Human Study to Assess The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ECC0509 in Healthy Volunteers.

Read the detailed description

This study will be conducted in up to seven cohorts of Single Ascending Dose (SAD) \& 3 cohorts of Multiple Ascending Dose (MAD). SAD will consist of a staggered dosing approach with a dose range from 1mg to 80mg. Staggered dosing approach will not be deployed for MAD cohorts with a dose range of 8mg to 40mg. In the MAD cohort, the effect of food will also be assessed by comparing the PK profile of Day 10 fed conditions against Day 14 fasted conditions.

Being tested
Placebo, ECC0509
Medical subject headings
Non-alcoholic Fatty Liver Disease, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Matching Placebo will be administered as oral capsules.

  • ECC0509Drug

    ECC0509 1 mg and 10 mg capsules. ECC0509 will be administered as oral capsules.

  • PlaceboDrug

    Matching Placebo will be given orally during each dosing day.

  • ECC0509Drug

    ECC0509 1 mg and 10 mg capsules

Study groups in NCT05012423
Study groupRoleWhat they receive
SAD Cohorts 1 to 6: Participants Receiving PlaceboPlacebo comparatorParticipants in each SAD cohort will be randomized to receive placebo.
Receives: Drug: Placebo
SAD Cohorts 1 to 6: Participants receiving ECC0509ExperimentalParticipants in each SAD cohort will be randomized to receive 1 of 6 escalating doses (1 mg, 4 mg, 10 mg, 20 mg, 40 mg, or 60 mg).
Receives: Drug: ECC0509
MAD Cohorts 1 to 4: Participants receiving PlaceboPlacebo comparatorParticipants will be randomized to receive a once-daily dose of placebo for 14 days.
Receives: Drug: Placebo
MAD Cohorts 1 to 4: Participants receiving ECC0509ExperimentalParticipants will be randomized to receive a once-daily dose of 1 of 4 escalating doses (3 mg, 10 mg, 30 mg, 60 mg) for 14 days.
Receives: Drug: ECC0509

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: SAD: Up to Day 8. MAD: Up to Day 21.

Secondary outcomes (18)

  1. ECC0509 PK parameters: Cl/F

    Apparent clearance

    Measured: SAD: Up to Day 8.

  2. ECC0509 PK parameters: Vz/F

    Apparent volume of distribution

    Measured: SAD: Up to Day 8.

  3. ECC0509 PK parameter: AUC0-24

    Area under the concentration-time curve from time zero to time 24 hours

    Measured: MAD: Up to Day 21

  4. ECC0509 PK parameter: Cmax ss

    Maximal observed concentration at steady-state

    Measured: MAD: Up to Day 21

  5. ECC0509 PK parameter: Tmax ss

    Time when the maximal concentration is observed at steady-state

    Measured: MAD: Up to Day 21

  6. ECC0509 PK parameter: Tlag ss

    Time prior to the first measurable (non-zero) concentration at steady-state

    Measured: MAD: Up to Day 21

  7. ECC0509 PK parameters: Cmax

    Maximal observed concentration

    Measured: SAD: Up to Day 8. MAD: Up to Day 21

  8. ECC0509 PK parameter: Tmax

    Time when the maximal concentration is observed

    Measured: SAD: Up to Day 8. MAD: Up to Day 21

  9. ECC0509 PK parameter: AUC0-t

    Area under the curve up to the last quantifiable time-point

    Measured: SAD: Up to Day 8. MAD: Up to Day 21

  10. ECC0509 PK parameter: Cmin ss

    Minimal observed concentration at steady-state

    Measured: MAD: Up to Day 21

  11. ECC0509 PK parameter: T½ el

    Terminal elimination half-life

    Measured: SAD: Up to Day 8. MAD: Up to Day 21

  12. ECC0509 PK parameter: Kel

    Terminal elimination rate constant

    Measured: SAD: Up to Day 8. MAD: Up to Day 21

  13. ECC0509 PK parameter: Clss/F

    Apparent body clearance at steady-state

    Measured: MAD: Up to Day 21

  14. ECC0509 PK parameter: Vz ss/F

    Apparent volume of distribution at steady-state

    Measured: MAD: Up to Day 21

  15. ECC0509 PK parameter: AUC0-τ

    Area under the concentration-time curve for one dosing interval (τ) at steady state.

    Measured: MAD: Up to Day 21

  16. ECC0509 PK parameters: AUC0-inf

    Area under the concentration-time curve from time zero to infinity

    Measured: SAD: Up to Day 8. MAD: Up to Day 21

  17. ECC0509 PK parameters: Residual area

    Percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity

    Measured: SAD: Up to Day 8. MAD: Up to Day 21

  18. PD Parameter: SSAO

    plasma semicarbazide-sensitive amine oxidase (SSAO) activity.

    Measured: SAD: Up to Day 8. MAD: Up to Day 21.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2021
  2. Study start26 Jul 2021
  3. Primary completion22 Jul 2023
  4. Study completion22 Jul 2023

Resources

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
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05012423
Sponsor's protocol ID
EC0001
Status last verified
Sep 2024
First submitted
22 Jul 2021
Last updated
25 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ECC0509 in people with Nonalcoholic Steatohepatitis and Osteoarthritis, 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 25 Sep 2024. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations (time frame: SAD: Up to Day 8. MAD: Up to Day 21.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05012423.

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 25 Sep 2024.

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