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A Study of EDP-323 in Healthy Subjects

Primary Purpose

RSV Infection

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

EDP-323

Placebo

About this trial

This is an interventional treatment trial for RSV Infection focused on measuring First-in-Human, Single Ascending Dose, Multiple Ascending Dose, Healthy Volunteer

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

ICON, plc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

EDP-323 SAD Cohorts

EDP-323 MAD Cohorts

EDP-323 SAD Placebo Cohorts

EDP-323 MAD Placebo Cohorts

Arm Description

EDP-323 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6, orally, once daily in one single administration

EDP-323 Dose 1, Dose 2, Dose 3 and Dose 4 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-323

AUC of EDP-323

Cmax of EDP-323

AUC of EDP-323

Full Information

NCT ID

NCT05587478

First Posted

October 17, 2022

Last Updated

August 31, 2023

Sponsor

Enanta Pharmaceuticals, Inc

1. Study Identification

Unique Protocol Identification Number

NCT05587478

Brief Title

A Study of EDP-323 in Healthy Subjects

Official Title

A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In- Human Study of Orally Administered EDP-323 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-323 Pharmacokinetics in Healthy Participants

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

September 29, 2022 (Actual)

Primary Completion Date

March 29, 2023 (Actual)

Study Completion Date

March 29, 2023 (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, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-323 in healthy adult subjects.

6. Conditions and Keywords

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

RSV Infection

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EDP-323 SAD Cohorts

Arm Type

Experimental

Arm Description

EDP-323 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6, orally, once daily in one single administration

Arm Title

EDP-323 MAD Cohorts

Arm Type

Experimental

Arm Description

EDP-323 Dose 1, Dose 2, Dose 3 and Dose 4 orally, once daily for 7 days

Arm Title

EDP-323 SAD Placebo Cohorts

Arm Type

Placebo Comparator

Arm Description

Matching placebo, orally, once daily in one single administration

Arm Title

EDP-323 MAD Placebo Cohorts

Arm Type

Placebo Comparator

Arm Description

Matching placebo, orally, once daily for 7 days

Intervention Type

Drug

Intervention Name(s)

EDP-323

Intervention Description

Oral administration

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to match EDP-323, oral administration

Primary Outcome Measure Information:

Title

Safety measured by adverse events

Time Frame

Up to 8 Days in SAD Cohorts

Title

Safety measured by adverse events

Time Frame

Up to 14 Days in MAD Cohorts

Secondary Outcome Measure Information:

Title

Cmax of EDP-323

Time Frame

Up to 5 Days in SAD Cohorts

Title

AUC of EDP-323

Time Frame

Up to 5 Days in SAD Cohorts

Title

Cmax of EDP-323

Time Frame

Up to 11 Days in MAD Cohorts

Title

AUC of EDP-323

Time Frame

Up to 11 Days in 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

ICON, plc.

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66219

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Study of EDP-323 in Healthy Subjects

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