A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2024-07-12

Brief Summary

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A randomized, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-323 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to assess the antiviral effect of EDP-323 compared to a placebo control in the respiratory syncytial virus challenge model.

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Detailed Description

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Conditions

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RSV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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EDP-323 Arm A

Subjects will take EDP-323 Dose 1 orally for 5 days

Group Type EXPERIMENTAL

EDP-323 Dose Regimen 1

Intervention Type DRUG

EDP-323 capsule

EDP-323 Arm B

Subjects will take EDP-323 Dose 2 orally for 5 days

Group Type EXPERIMENTAL

EDP-323 Dose Regimen 2

Intervention Type DRUG

EDP-323 capsule

Placebo Arm C

Subjects will take matching placebo orally for 5 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsule

Interventions

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EDP-323 Dose Regimen 1

EDP-323 capsule

Intervention Type DRUG

EDP-323 Dose Regimen 2

EDP-323 capsule

Intervention Type DRUG

Placebo

Placebo capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* An informed consent document signed and dated by the subject.
* Age 18 to 55 years, inclusive.
* In good health with no history of major medical conditions.
* A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 35kg/m2.

Exclusion Criteria

* Pregnant or nursing females
* Acute or chronic medical illness
* History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (URT or LRT) infection within 4 weeks prior to the first study visit.
* Abnormal lung function
* Positive for HIV, active hepatitis B or C test
* Nose or nasopharynx abnormalities
* Receipt of any investigational drug within 3 months prior to the planned date of viral challenge/first dose of study drug

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes