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SAD Cohorts 1 to 2: Participants receiving ECC4703 for Non-alcoholic Fatty Liver Disease
Phase < 1
Waitlist Available
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
Summary
This trial tests a new drug called ECC4703 in healthy people and those with slightly elevated cholesterol. It aims to see how the drug is processed by and affects the body.
Eligible Conditions
- Non-alcoholic Fatty Liver Disease (NAFLD)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ sad: up to day 8 and mad: up to day 21.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sad: up to day 8 and mad: up to day 21.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Electrocardiogram
Secondary study objectives
Pharmacodynamic assessment: ApoB
Pharmacodynamic assessment: Glucose
Pharmacodynamic assessment: HDL-C
+25 moreTrial 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ECC4703
2022
Completed Early Phase 1
~80
Find a Location
Who is running the clinical trial?
EccogeneLead Sponsor
4 Previous Clinical Trials
220 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
89 Patients Enrolled for Non-alcoholic Fatty Liver Disease
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