A Study of EDP-235 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-235 in healthy adult subjects.

Detailed Description
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The first phase assesses single ascending doses of EDP-235 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-235 or placebo for 7-days in healthy subjects. Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-235 or placebo.

Official Title
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A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First In Human Study of Orally Administered EDP-235 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-235 Pharmacokinetics in Healthy Participants

Conditions
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SARS CoV 2 Infection

Intervention / Treatment
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* Drug: EDP-235
* 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. Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening and infection with SARS-CoV-2 at the Day -1 visit 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 -1. Current tobacco smokers or use of tobacco within 3 months prior to screening. Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). History of regular alcohol consumption. Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose.

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-235 SAD Cohorts<br>EDP-235 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5, orally, once daily in one single administration | Drug: EDP-235<br>* Oral administration<br>|
| Experimental: EDP-235 MAD Cohorts<br>EDP-235 Dose 1, Dose 2 and Dose 3 orally, once daily for 7 days | Drug: EDP-235<br>* Oral administration<br>|
| Placebo Comparator: EDP-235 SAD Placebo Cohorts<br>Matching placebo, orally, once daily in one single administration | Drug: Placebo<br>* Placebo to match EDP-235, oral administration<br>|
| Placebo Comparator: EDP-235 MAD Placebo Cohorts<br>Matching placebo, orally, once daily for 7 days | Drug: Placebo<br>* Placebo to match EDP-235, oral administration<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 HV SAD Cohorts | 
| Safety measured by adverse events |  | Up to 14 Days in HV MAD Cohorts | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of EDP-235 |  | Up to 5 Days in HV SAD Cohorts | 
| AUC of EDP-235 |  | Up to 5 Days in HV SAD Cohorts | 
| Cmax of EDP-235 |  | Up to 11 Days in HV MAD Cohorts | 
| AUC of EDP-235 |  | Up to 11 Days in HV MAD Cohorts | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single Ascending Dose, COVID-19, First-in-Human, Multiple Ascending Dose, Healthy Volunteer