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SAD Cohorts 1 to 2: Participants receiving ECC4703 for Non-alcoholic Fatty Liver Disease

Phase < 1
Recruiting
Research Sponsored by Eccogene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy male and female participants of any ethnic origin
BMI of 18.0 to 32.0 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up sad: up to day 8 and mad: up to day 21.
Awards & highlights

Study Summary

This trial is testing a new drug, ECC4703, to see if it is safe and effective in healthy volunteers and people with LDL-C levels below 160 mg/dL. The study will give increasing doses of the drug to different groups of people to see what effects it has.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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People of any ethnic background who are in good health can participate.
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Your weight falls within a specific range based on your height, known as body mass index (BMI).
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You must have a normal physical exam, normal vital signs, normal lab results, and no significant medical or mental health history.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sad: up to day 8 and mad: up to day 21.
This trial's timeline: 3 weeks for screening, Varies for treatment, and sad: up to day 8 and mad: up to day 21. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Electrocardiogram
Secondary outcome measures
Pharmacodynamic assessment: ApoB
Pharmacodynamic assessment: Glucose
Pharmacodynamic assessment: HDL-C
+25 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: SAD Cohorts 1 to 2: Participants receiving ECC4703Experimental Treatment1 Intervention
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).
Group II: MAD Cohorts 1 to 4: Participants receiving ECC4703Experimental Treatment1 Intervention
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.
Group III: SAD Cohorts 1 to 2: Participants receiving PlaceboPlacebo Group1 Intervention
Participants in each SAD cohort will be randomized to receive placebo
Group IV: MAD Cohorts 1 to 4: Participants receiving PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive a once-daily dose of placebo for 14 days.

Find a Location

Who is running the clinical trial?

EccogeneLead Sponsor
3 Previous Clinical Trials
142 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current status of enrollment in this experiment?

"This study, which originally appeared on clinicaltrials.gov on August 16th 2022 is presently seeking participants. The most recent edit was made to the listing on September 20th 2022."

Answered by AI

How many test subjects are taking part in this clinical trial?

"Affirmative. Data found on clinicaltrials.gov attests to the fact that this medical experiment, first published on August 16th 2022, is in need of volunteers. 54 individuals are required to be sourced from a single facility."

Answered by AI

Is it possible to join this experiment if you are of legal age?

"This clinical trial is open to participants who are of legal age and have not yet entered their senior years."

Answered by AI

Who is the ideal candidate for this medical study?

"This clinical trial demands 54 individuals of age 18-65 suffering from steatohepatitis. The essential criteria are as follows: the participant has BMI between 18 to 32kg/m2; female participants should be postmenopausal, surgically sterile, or use contraception; male participants must also utilize contraception or practice abstinence; no medical complications in physical checkup with 12 lead ECG and vital sign measurements; not utilizing any medication regularly; comprehends and signs informed consent form; fasting LDL cholesterol content is within 100 mg/dL - 159 mg/dL at screening. Moreover, additional inclusion criteria for Part 2 MAD Cohorts B2 to"

Answered by AI
~21 spots leftby Mar 2025