Non-alcoholic Steatohepatitis (NASH)Early Phase 1NCT05552274
FTIH of ECC4703 in Healthy Volunteers
A Early Phase 1 study testing ECC4703 in people with Non-alcoholic Steatohepatitis (NASH), run by Eccogene at 1 site in United States.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ECC4703 in healthy volunteers and participants with treatment unnecessary LDL-C under 160 mg/dL Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Steatohepatitis (NASH)
- What is being tested?
- ECC4703
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2022to 26 Oct 2023
- Phase
- Early 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 and female participants of any ethnic origin
- Age of 18 to 65 years
- BMI of 18.0 to 32.0 kg/m2
- Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, or if they are of child bearing potential agree to use at least 1 highly effective method of contraception and 1 additional effective method at the same time, or agree to practice true abstinence
- Male participants agree to use contraception, or agree to practice true abstinence
- No clinically significant findings in physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, laboratory tests, or medical/psychiatric history
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- Not taking any medication on a regular basis
- Able to understand and sign and date informed consent
- Additional Inclusion Criteria for Part 2 (MAD) Cohorts B2 to B4
- Fasting LDL-C ≥ 100 mg/dL and ≤ 159 mg/dL at screening
- Not eligible for lipid-lowering therapy (such as statin) as decided by the qualified clinician at screening based on <2019 ACC/AHA Guidelines on the Primary Prevention of Cardiovascular Disease>
- Hemoglobin A1c (HbA1c) ≤ 6.5%.
Who cannot join
- Females who are pregnant including a positive result of pregnancy test, planning to become pregnant, or breastfeeding.
- History of febrile illness or evidence of active infection within 14 days prior to the first dose of study;
- Use of any concomitant medication
- History of drug abuse or alcohol abuse within the past 5 years;
- Regular use of tobacco, nicotine or tobacco products within the past 6 months of the study ;
- Unwilling to abstain from alcohol containing products and/or xanthine/caffeine containing products, including any food and beverages, within 48 h prior to the first dose of study drug;
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- Concomitant participation in any investigational study of any nature
- Blood loss of non-physiological reasons ≥ 200 ml (i.e. trauma, blood collection, blood donation) within 2 months prior to the first dose of study drug, or plan to donate blood during this trial and within 1 month after the last dosing;
- Abnormal renal function estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m2
- Currently diagnosed type 2 diabetes mellitus (T2DM) or has history of T2DM.
- Significant allergic reaction to active ingredients or excipients of the study drug.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eccogene Investigational Site
Las Vegas, Nevada, 89113
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Repeated Dose Escalation, FTIH Study to Investigate the Safety, Tolerability, PK and PD of ECC4703 in Healthy Volunteers and Participants With Treatment-Unnecessary LDL-C Under 160 mg/dL
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ECC4703 in healthy volunteers and participants with treatment unnecessary LDL-C under 160 mg/dL
Read the detailed description
This study will be conducted in two cohorts of Single Ascending Dose (SAD) with a dose range from 1mg to 400mg and in four cohorts of Multiple Ascending Dose (MAD) with a dose range of 40mg to 160mg to Investigate the Safety, Tolerability, PK, and PD of ECC4703 in Healthy Volunteers and Participants with Treatment Unnecessary LDL-C under 160 mg/dL
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Being tested
- ECC4703, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECC4703Drug
ECC4703 will be administered as 1 mg, 10 mg and 40 mg capsules. ECC4703 will be administered as oral capsules during each dosing day.
PlaceboDrug
Matching Placebo will be administered as oral capsules. Matching Placebo will be given orally during each dosing day.
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohorts 1 to 2: Participants receiving Placebo | Placebo comparator | Participants in each SAD cohort will be randomized to receive placebo Receives: Drug: Placebo |
| SAD Cohorts 1 to 2: Participants receiving ECC4703 | Experimental | Participants in each SAD cohort will be randomized to receive up to 4 escalating doses (1 mg, 4 mg, 12 mg, 32 mg, 80 mg, 160 mg, 320 mg or 400 mg). Receives: Drug: ECC4703 |
| MAD Cohorts 1 to 4: Participants receiving Placebo | Placebo comparator | Participants will be randomized to receive a once-daily dose of placebo for 14 days. Receives: Drug: Placebo |
| MAD Cohorts 1 to 4: Participants receiving ECC4703 | Experimental | Participants will be randomized to receive a once-daily dose of 1 of 3 escalating doses (40 mg, 80 mg, or 160 mg) for 14 days. Receives: Drug: ECC4703 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 8 days and MAD: Up to 21 days
Secondary outcomes (28)
Pharmacokinetic Parameters: AUC0-24
AUC from time 0 to 24 hour dosing interval
Measured: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: AUC0-tlast
AUC from time 0 to the time of last quantifiable non-zero concentration
Measured: SAD: Up to Day 8
Pharmacokinetic Parameters: AUC0-tau
AUC over a dosing interval from time 0 to time of last quantifiable concentration
Measured: MAD: Up to Day 21.
Pharmacokinetic Parameters: AUC0-infinity
AUC from time 0 extrapolated to infinity
Measured: SAD: Up to Day 8
Pharmacokinetic Parameters: Cmax
Maximum observed plasma concentration
Measured: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: C24
Observed concentration at 24 hours post dose
Measured: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: Ctau
Observed concentration at the end of the dosing interval
Measured: MAD: Up to Day 21.
Pharmacokinetic Parameters: tmax
Time of the maximum observed plasma concentration
Measured: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: tlag
Lag time (time delay between dosing and first observed plasma concentration)
Measured: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: t1/2
Apparent terminal elimination half-life
Measured: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: Clast
Last measurable non-zero concentration
Measured: SAD: Up to Day 8
Pharmacokinetic Parameters: tlast
Time of last measurable non-zero concentration
Measured: SAD: Up to Day 8
Pharmacokinetic Parameters: CL/F
Apparent Clearance
Measured: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacodynamic assessment: LDL-C
Measurement of Low Density Lipoprotein Cholesterol
Measured: SAD: Up to Day 8
Pharmacodynamic assessment: HDL-C
Measurement of High Density Lipoprotein Cholesterol
Measured: MAD: Up to Day 21.
Pharmacodynamic assessment: TG
Measurement of Triglycerides
Measured: MAD: Up to Day 21.
Pharmacodynamic assessment: TC
Measurement of Total Cholesterol
Measured: MAD: Up to Day 21.
Pharmacodynamic assessment: LDL
Measurement of Low Density Lipoprotein
Measured: MAD: Up to Day 21.
Pharmacodynamic assessment: VLDL
Measurement of Very Low Density Lipoprotein
Measured: MAD: Up to Day 21.
Pharmacodynamic assessment: ApoB
Measurement of Apolipoprotein B
Measured: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacodynamic assessment: Lp(a)
Measurement of Lipoprotein (a)
Measured: MAD: Up to Day 21.
Pharmacodynamic assessment: Glucose
Measurement of Glucose
Measured: MAD: Up to Day 21.
Pharmacodynamic assessment: Serum Insulin
Measurement of Serum Insulin
Measured: MAD: Up to Day 21.
Thyroid function assessment: TT3
Measurement of Total Triiodothyronine
Measured: SAD: Up to Day 8 and MAD: Up to Day 21.
Thyroid function assessment: FT3
Measurement of Free Triiodothyronine
Measured: SAD: Up to Day 8 and MAD: Up to Day 21.
Thyroid function assessment: TT4
Measurement of Total Thyroxine
Measured: SAD: Up to Day 8 and MAD: Up to Day 21.
Thyroid function assessment: FT4
Measurement of Free Thyroxine
Measured: SAD: Up to Day 8 and MAD: Up to Day 21.
Thyroid function assessment: TSH
Measurement of Thyroid Stimulating Hormone
Measured: SAD: Up to Day 8 and 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.
- First posted23 Sep 2022
- Study start16 Aug 2022
- Primary completion26 Oct 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Steatohepatitis (NASH)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eccogene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eccogene, Study director, Eccogene Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552274
- Sponsor's protocol ID
- EC0002
- Status last verified
- Jul 2024
- First submitted
- 13 Sep 2022
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single and Repeated Dose Escalation, FTIH Study to Investigate the Safety, Tolerability, PK and PD of ECC4703 in Healthy Volunteers and Participants With Treatment-Unnecessary LDL-C Under 160 mg/dL
- ClinicalTrials.gov ID
- NCT05552274
- Acronym / sponsor ID
- EC0002
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- EccogeneIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 23 Sep 2022 (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 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ECC4703 in healthy volunteers and participants with treatment unnecessary LDL-C under 160 mg/dL
Detailed description
This study will be conducted in two cohorts of Single Ascending Dose (SAD) with a dose range from 1mg to 400mg and in four cohorts of Multiple Ascending Dose (MAD) with a dose range of 40mg to 160mg to Investigate the Safety, Tolerability, PK, and PD of ECC4703 in Healthy Volunteers and Participants with Treatment Unnecessary LDL-C under 160 mg/dL
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAD Cohorts 1 to 2: Participants receiving Placebo | Placebo comparator | Drug: PlaceboParticipants in each SAD cohort will be randomized to receive placebo |
| SAD Cohorts 1 to 2: Participants receiving ECC4703 | Experimental | Drug: ECC4703Participants in each SAD cohort will be randomized to receive up to 4 escalating doses (1 mg, 4 mg, 12 mg, 32 mg, 80 mg, 160 mg, 320 mg or 400 mg). |
| MAD Cohorts 1 to 4: Participants receiving Placebo | Placebo comparator | Drug: PlaceboParticipants will be randomized to receive a once-daily dose of placebo for 14 days. |
| MAD Cohorts 1 to 4: Participants receiving ECC4703 | Experimental | Drug: ECC4703Participants will be randomized to receive a once-daily dose of 1 of 3 escalating doses (40 mg, 80 mg, or 160 mg) for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy male and female participants of any ethnic origin
- Age of 18 to 65 years
- BMI of 18.0 to 32.0 kg/m2
- Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, or if they are of child bearing potential agree to use at least 1 highly effective method of contraception and 1 additional effective method at the same time, or agree to practice true abstinence
- Male participants agree to use contraception, or agree to practice true abstinence
Key exclusion criteria (12 listed)
- Females who are pregnant including a positive result of pregnancy test, planning to become pregnant, or breastfeeding.
- History of febrile illness or evidence of active infection within 14 days prior to the first dose of study;
- Use of any concomitant medication
- History of drug abuse or alcohol abuse within the past 5 years;
- Regular use of tobacco, nicotine or tobacco products within the past 6 months of the study ;
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 |
|---|---|---|
| ECC4703ECC4703 will be administered as 1 mg, 10 mg and 40 mg capsules. ECC4703 will be administered as oral capsules during each dosing day. | Drug | MAD Cohorts 1 to 4: Participants receiving ECC4703, SAD Cohorts 1 to 2: Participants receiving ECC4703 |
| PlaceboMatching Placebo will be administered as oral capsules. Matching Placebo will be given orally during each dosing day. | Drug | MAD Cohorts 1 to 4: Participants receiving Placebo, SAD Cohorts 1 to 2: Participants receiving Placebo |
Primary outcome
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 8 days and MAD: Up to 21 days
Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.
28 secondary outcomes
Pharmacokinetic Parameters: AUC0-24
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: AUC0-tlast
Time frame: SAD: Up to Day 8
Pharmacokinetic Parameters: AUC0-tau
Time frame: MAD: Up to Day 21.
Pharmacokinetic Parameters: AUC0-infinity
Time frame: SAD: Up to Day 8
Pharmacokinetic Parameters: Cmax
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: C24
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: Ctau
Time frame: MAD: Up to Day 21.
Pharmacokinetic Parameters: tmax
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: tlag
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: t1/2
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacokinetic Parameters: Clast
Time frame: SAD: Up to Day 8
Pharmacokinetic Parameters: tlast
Time frame: SAD: Up to Day 8
Pharmacokinetic Parameters: CL/F
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacodynamic assessment: LDL-C
Time frame: SAD: Up to Day 8
Pharmacodynamic assessment: HDL-C
Time frame: MAD: Up to Day 21.
Pharmacodynamic assessment: TG
Time frame: MAD: Up to Day 21.
Pharmacodynamic assessment: TC
Time frame: MAD: Up to Day 21.
Pharmacodynamic assessment: LDL
Time frame: MAD: Up to Day 21.
Pharmacodynamic assessment: VLDL
Time frame: MAD: Up to Day 21.
Pharmacodynamic assessment: ApoB
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Pharmacodynamic assessment: Lp(a)
Time frame: MAD: Up to Day 21.
Pharmacodynamic assessment: Glucose
Time frame: MAD: Up to Day 21.
Pharmacodynamic assessment: Serum Insulin
Time frame: MAD: Up to Day 21.
Thyroid function assessment: TT3
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Thyroid function assessment: FT3
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Thyroid function assessment: TT4
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Thyroid function assessment: FT4
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Thyroid function assessment: TSH
Time frame: SAD: Up to Day 8 and MAD: Up to Day 21.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- 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. This study is not recruiting at the moment.
Eccogene study director
Eccogene Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ECC4703 in people with Non-alcoholic Steatohepatitis (NASH), run by Eccogene at 1 site in United States.
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 12 inclusion and 12 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 5 Jul 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 8 days and MAD: Up to 21 days). 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 5 Jul 2024.