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A Study of EDP-235 in Healthy Subjects

Primary Purpose

SARS CoV 2 Infection

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

EDP-235

Placebo

About this trial

This is an interventional treatment trial for SARS CoV 2 Infection focused on measuring First-in-Human, Single Ascending Dose, Multiple Ascending Dose, Healthy Volunteer, COVID-19

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Pharmaceutical Research Associates, Inc.,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

EDP-235 SAD Cohorts

EDP-235 MAD Cohorts

EDP-235 SAD Placebo Cohorts

EDP-235 MAD Placebo Cohorts

Arm Description

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

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

Matching placebo, orally, once daily in one single administration

Matching placebo, orally, once daily for 7 days

Outcomes

Primary Outcome Measures

Safety measured by adverse events

Secondary Outcome Measures

Cmax of EDP-235

AUC of EDP-235

Cmax of EDP-235

AUC of EDP-235

Full Information

NCT ID

NCT05246878

First Posted

February 9, 2022

Last Updated

August 18, 2022

Sponsor

Enanta Pharmaceuticals, Inc

1. Study Identification

Unique Protocol Identification Number

NCT05246878

Brief Title

A Study of EDP-235 in Healthy Subjects

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

January 28, 2022 (Actual)

Primary Completion Date

July 20, 2022 (Actual)

Study Completion Date

July 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Enanta Pharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS CoV 2 Infection

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EDP-235 SAD Cohorts

Arm Type

Experimental

Arm Description

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

Arm Title

EDP-235 MAD Cohorts

Arm Type

Experimental

Arm Description

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

Arm Title

EDP-235 SAD Placebo Cohorts

Arm Type

Placebo Comparator

Arm Description

Matching placebo, orally, once daily in one single administration

Arm Title

EDP-235 MAD Placebo Cohorts

Arm Type

Placebo Comparator

Arm Description

Matching placebo, orally, once daily for 7 days

Intervention Type

Drug

Intervention Name(s)

EDP-235

Intervention Description

Oral administration

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to match EDP-235, oral administration

Primary Outcome Measure Information:

Title

Safety measured by adverse events

Time Frame

Up to 8 Days in HV SAD Cohorts

Title

Safety measured by adverse events

Time Frame

Up to 14 Days in HV MAD Cohorts

Secondary Outcome Measure Information:

Title

Cmax of EDP-235

Time Frame

Up to 5 Days in HV SAD Cohorts

Title

AUC of EDP-235

Time Frame

Up to 5 Days in HV SAD Cohorts

Title

Cmax of EDP-235

Time Frame

Up to 11 Days in HV MAD Cohorts

Title

AUC of EDP-235

Time Frame

Up to 11 Days in HV MAD Cohorts

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Enanta Pharmaceuticals, Inc

Organizational Affiliation

Enanta Pharmaceuticals, Inc

Official's Role

Study Director

Facility Information:

Facility Name

Pharmaceutical Research Associates, Inc.,

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66219

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study of EDP-235 in Healthy Subjects

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