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

Study Overview
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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.

Official Title
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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 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy Adults

Conditions
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RSV Infection

Intervention / Treatment
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* Drug: EDP-323 Dose Regimen 1
* Drug: EDP-323 Dose Regimen 2
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDP-323 Arm A<br>Subjects will take EDP-323 Dose 1 orally for 5 days | Drug: EDP-323 Dose Regimen 1<br>* EDP-323 capsule<br>|
| Experimental: EDP-323 Arm B<br>Subjects will take EDP-323 Dose 2 orally for 5 days | Drug: EDP-323 Dose Regimen 2<br>* EDP-323 capsule<br>|
| Placebo Comparator: Placebo Arm C<br>Subjects will take matching placebo orally for 5 days | Drug: Placebo<br>* Placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in viral load measurements | Area under the curve for RSV viral load as measured by RT-qPCR assay from the first viral load measurement post initial dose of EDP-323 or placebo through day 12 | Post initial dose of EDP-323 up to Day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Symptom Score (TSS) | Area Under the Curve (AUC) of TSS through Day 12 | Innoculation through Day 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RSV, challenge study, antiviral, RSV-A Memphis 37b