A Study of EDP-235 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-28

Study Completion Date

2022-07-20

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.

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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.

Conditions

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SARS CoV 2 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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EDP-235 SAD Cohorts

EDP-235 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5, orally, once daily in one single administration

Group Type EXPERIMENTAL

EDP-235

Intervention Type DRUG

Oral administration

EDP-235 MAD Cohorts

EDP-235 Dose 1, Dose 2 and Dose 3 orally, once daily for 7 days

Group Type EXPERIMENTAL

EDP-235

Intervention Type DRUG

Oral administration

EDP-235 SAD Placebo Cohorts

Matching placebo, orally, once daily in one single administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match EDP-235, oral administration

EDP-235 MAD Placebo Cohorts

Matching placebo, orally, once daily for 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match EDP-235, oral administration

Interventions

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EDP-235

Oral administration

Intervention Type DRUG

Placebo

Placebo to match EDP-235, oral administration

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes