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

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.

Study Overview

• Status: Completed
• Conditions: SARS CoV 2 Infection
• Intervention / Treatment: Drug: EDP-235; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Pharmaceutical Research Associates, Inc.,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EDP-235 SAD Cohorts; EDP-235 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5, orally, once daily in one single administration	Drug: EDP-235; Oral administration
EXPERIMENTAL: EDP-235 MAD Cohorts; EDP-235 Dose 1, Dose 2 and Dose 3 orally, once daily for 7 days	Drug: EDP-235; Oral administration
PLACEBO_COMPARATOR: EDP-235 SAD Placebo Cohorts; Matching placebo, orally, once daily in one single administration	Drug: Placebo; Placebo to match EDP-235, oral administration
PLACEBO_COMPARATOR: EDP-235 MAD Placebo Cohorts; Matching placebo, orally, once daily for 7 days	Drug: Placebo; Placebo to match EDP-235, oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Enanta Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 28, 2022
• Primary Completion (ACTUAL): July 20, 2022
• Study Completion (ACTUAL): July 20, 2022

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (ACTUAL): February 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: First-in-Human; Healthy Volunteer; COVID-19; Single Ascending Dose; Multiple Ascending Dose
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: EDP 235-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No