A Study of EDP-235 in Healthy Subjects

Phase 1

Completed

• Conditions: SARS CoV 2 Infection
• Interventions: Drug: Placebo; Drug: EDP-235

• Registration Number: NCT05246878
• Lead Sponsor: Enanta Pharmaceuticals, Inc

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.

Study Timeline

• Study Start: 2022-01-28
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-18
• Primary Completion: 2022-07-20
• Study Completion: 2022-07-20
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-18
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EDP-235 MAD Placebo Cohorts	Placebo	Matching placebo, orally, once daily for 7 days
EDP-235 SAD Cohorts	EDP-235	EDP-235 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5, orally, once daily in one single administration
EDP-235 MAD Cohorts	EDP-235	EDP-235 Dose 1, Dose 2 and Dose 3 orally, once daily for 7 days
EDP-235 SAD Placebo Cohorts	Placebo	Matching placebo, orally, once daily in one single administration

Primary Outcome Measures

Name	Time	Method
Safety measured by adverse events	Up to 14 Days in HV MAD Cohorts

Secondary Outcome Measures

Name	Time	Method
Cmax of EDP-235	Up to 11 Days in HV MAD Cohorts
AUC of EDP-235	Up to 11 Days in HV MAD Cohorts

Trial Locations

Locations (1)

Pharmaceutical Research Associates, Inc.,; 🇺🇸 Lenexa, Kansas, United States