A Study of EDP-235 in Healthy Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05246878

Enrollment

Registered

2022-02-18

Start date

2022-01-28

Completion date

2022-07-20

Last updated

2022-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS CoV 2 Infection

Keywords

First-in-Human, Single Ascending Dose, Multiple Ascending Dose, Healthy Volunteer, COVID-19

Brief summary

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

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.

Interventions

DRUGEDP-235

Oral administration

DRUGPlacebo

Placebo to match EDP-235, oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Safety measured by adverse events	Up to 8 Days in HV SAD Cohorts

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026