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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
Be older than 18 years old
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)

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
~20 spots leftby May 2025
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