A Study to Evaluate EDP 938 Regimens in Children With RSV

Study Overview
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Brief Summary
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A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection.

Detailed Description
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This is a randomized, double-blind, dose ranging, placebo-controlled study in respiratory syncytial virus (RSV) among hospitalized and non-hospitalized children aged from 28 days to 36 months, assessing the safety, tolerability, pharmacokinetics, clinical outcome and antiviral activity of a 5 day treatment with EDP-938.

Official Title
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A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-PART STUDY TO EVALUATE EDP-938 REGIMENS IN SUBJECTS AGED 28 DAYS TO 36 MONTHS INFECTED WITH RESPIRATORY SYNCYTIAL VIRUS (RSV)

Conditions
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Respiratory Syncytial Virus (RSV)

Intervention / Treatment
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* Drug: EDP-938
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female who is either ≥6 months to ≤36 months (for Age Group 1) or ≥28 days to <6 months (for Age Group 2), defined at the time of randomization. Subjects in Age Group 2 must have been born ≥29 weeks of gestation to be eligible. Subjects diagnosed with RSV infection Subjects with signs of an acute respiratory illness with onset ≤7 days before the time of signing the ICF In the Investigator's opinion, the subject's caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned Exclusion Criteria: Use of or anticipated need for invasive mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness Underlying immune deficiency, (e.g., from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin A deficiency) Receipt of (within 12 months before Screening) or on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening) Receiving chronic oxygen therapy at home before admission Receiving an investigational or approved medication that is intended to prevent or treat RSV infection within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug, and/or is currently enrolled in a clinical trial of such a medication. RSV-specific monoclonal antibodies are not prohibited in Part 1.

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDP-938<br>EDP-938, oral suspension, once daily for 5 days | Drug: EDP-938<br>* Oral suspension<br>|
| Placebo Comparator: Placebo<br>Matching placebo, orally, once daily for 5 days | Drug: Placebo<br>* Placebo oral suspension to match EDP-938<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of EDP-938 (Part 1) |  | Up to 5 days | 
| Predose concentration of EDP-938 (Part 1) |  | Up to 5 days | 
| Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 1) |  | Up to 29 Days | 
| Daily change from baseline in RSV shedding (Part 2) |  | Up to 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC for RSV RNA viral load (Part 1 and Part 2) |  | Up to 14 Days | 
| Daily change in RSV shedding (Part 1) |  | Up to 14 Days | 
| Proportion of subjects with undetectable level of RSV RNA viral load (Part 1 and Part 2) |  | Up to 14 Days | 
| Time to RSV RNA viral load being undetectable (Part 1 and Part 2) |  | Up to 14 Days | 
| AUC of EDP-938 (Part 2) |  | Up to 5 Days | 
| Predose concentration of EDP-938 (Part 2) |  | Up to 5 Days | 
| Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 2) |  | Up to 29 Days | 
| Time to discharge for hospitalized subjects (Part 2) |  | Up to 29 Days | 
| Time to use of oxygen for hospitalized subjects who are not receiving oxygen at the time they receive the first dose of study drug (Part 2) |  | Up to 29 Days | 
| Proportion of hospitalized subjects requiring oxygen supplementation or have an increased oxygen requirement |  | Up to 29 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Syncytial Virus, RSV, Pediatric study