A Study of EDP-297 in Healthy Subjects

Study Overview
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Brief Summary
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This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.

Detailed Description
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The first phase assesses single ascending doses of EDP-297 or placebo in healthy subjects. A fasted and fed two-part cohort will also assess food effect. The second phase assesses multiple ascending doses of EDP-297 or placebo for 14-days in healthy subjects. Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-297 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-297 or placebo

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-297 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD), and the Effect of Food on EDP-297 Pharmacokinetics in Healthy Subjects

Conditions
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NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis

Intervention / Treatment
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* Drug: EDP-297
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An informed consent document signed and dated by the subject. Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive. Exclusion Criteria: Clinically relevant evidence or history of illness or disease. Pregnant or nursing females. History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection. A positive urine drug screen at screening or Day -2. Current tobacco smokers or use of tobacco within 1 months prior to screening. Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). History of regular alcohol consumption exceeding 14 drinks/week for females and 21 drinks/week for males within 6 months of Screening. Participation in a clinical trial within 30 days prior to the first dose of study drug.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDP-297 SAD Cohorts<br>EDP-297 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral solution, once daily in one single administration | Drug: EDP-297<br>* EDP-297 Oral solution<br>|
| Experimental: EDP-297 MAD Cohorts<br>EDP-297 Dose 1, Dose 2 and Dose 3 oral solution, once daily for 14 days | Drug: EDP-297<br>* EDP-297 Oral solution<br>|
| Placebo Comparator: EDP-297 SAD Placebo Cohort<br>Matching placebo, oral solution, once daily in one single administration | Drug: Placebo<br>* placebo to match EDP-297<br>|
| Placebo Comparator: EDP-297 MAD Placebo Cohort<br>Matching placebo, oral solution, once daily for 14 days | Drug: Placebo<br>* placebo to match EDP-297<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by adverse events |  | Up to 8 Days in SAD Cohorts | 
| Safety measured by adverse events |  | Up to 21 Days in MAD Cohorts | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of EDP-297 |  | Up to 6 Days in SAD Cohorts | 
| Cmax of EDP-297 |  | Up to 18 Days in MAD Cohorts | 
| AUC of EDP-297 |  | Up to 6 Days in SAD Cohorts | 
| AUC of EDP-297 |  | Up to 18 Days in MAD Cohorts | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First-in-Human, Single Ascending Dose, Multiple Ascending Dose, Healthy Volunteer