A Study to Evaluate EDP 938 Regimens in Children With RSV (RSVPEDs)

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)

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

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus (RSV)
• Intervention / Treatment: Drug: EDP-938; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Bahía Blanca, Argentina
    • Hospital Interzonal Dr Jose Penna
  • Buenos Aires, Argentina, C1425
    • Clínica Privada del Sol
  • Río Cuarto, Argentina
    • Instituto Medico Rio Cuarto
  • Villa Regina, Argentina
    • Clinica Central S.A
  • Buenos Aires
    • Mar Del Plata, Buenos Aires, Argentina
      • Clinica del Niño y la Familia
• Australia
  • Southport, Australia
    • Gold Coast University Hospital
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Sydney Children's Hospital - Randwick
    • Westmead, New South Wales, Australia, 2145
      • The Children's Hospital at Westmead
• Brazil
  • Curitiba, Brazil, 80060-900
    • Universidade Federal do Parana - Hospital de Clínicas
  • Ribeirão Preto, Brazil, 14015-010
    • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
  • Rio Grande Do Sul
    • Passo Fundo, Rio Grande Do Sul, Brazil, 99010
      • Instituto Mederi de Pesquisa e Saude
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035
      • Hospital De Clinicas De Porto Alegre
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035
      • Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre
• Germany
  • Erlangen, Germany
    • Universitatsklinikum Erlangen
  • Sankt Augustin, Germany
    • Asklepios Klinik Sankt Augustin
  • Bundesland
    • Marburg, Bundesland, Germany, 35043
      • Universitätsklinikum Gießen und Marburg - Gießen
• Israel
  • Be'er Sheva, Israel
    • Soroka University Medical Center
  • Haifa, Israel
    • Carmel Medical Center
  • Haifa, Israel, 3109601
    • Rambam Health Care
  • Jerusalem, Israel
    • Hadassah University Hospital Mount Scopu
  • Petach Tikva, Israel, 4920235
    • Schneider Children's Medical Center of Israel
• Korea, Republic of
  • Seoul, Korea, Republic of, 2447
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of
    • Inje University Sanggye Paik Hospital
  • Seoul, Korea, Republic of, 1830
    • Nowon Eulji Medical Center, Eulji University
• Mexico
  • Mexico City, Mexico, 04530
    • Instituto Nacional de Pediatría
  • Mexico City, Mexico
    • Hospital Infantil de Mexico Federico Gomez
  • Mexico City, Mexico
    • Karla Adriana Espinosa Bautista
  • Monterrey, Mexico
    • IESCI Clinical Research
  • Querétaro, Mexico
    • PanAmerican Clinical Research
  • Querétaro, Mexico
    • SMIQ S de R.L de C.V
  • Prados
    • Guadalajara, Prados, Mexico, 44670
      • PanAmerican Clinical Research Mexico - Guadalajara
• New Zealand
  • Wellington
    • Newtown, Wellington, New Zealand
      • Wellington Regional Hospital
• Poland
  • Bydgoszcz, Poland
    • IN-VIVO Bydgoszcz
  • Łódź, Poland
    • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
• Romania
  • Bucharest, Romania
    • Institutul National pentru Sanatatea Mamei si Copilului "Alessandrescu-Rusescu"
  • Brașov
    • Braşov, Brașov, Romania
      • Spital Clinic de Urgenta Pentru Copii Brasov
  • Târgu Mureș
    • Târgu-Mureş, Târgu Mureș, Romania
      • Spitalul Clinic Judetean de Urgenta Targu Mures
• South Africa
  • Johannesburg, South Africa
    • Rahima Moosa Mother and Child Hospital
  • Soweto, South Africa, 2013
    • Wits Clinical Research
  • Durban
    • Westville, Durban, South Africa
      • Life Westville Hospital
• Spain
  • Barcelona, Spain
    • Hospital Germans Trias i Pujol
  • Lleida, Spain
    • Hospital Universitario Arnau de Vilanova
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain
    • Hospital Universitario Puerta de Hierro - Majadahonda
  • Madrid, Spain
    • Hospital Universitario Quironsalud Madrid
  • Madrid, Spain
    • Hospital Universitario Severo Ochoa
  • Madrid, Spain
    • Unidad de Ensayos Clínicos Pediátricos
  • Málaga, Spain
    • Hospital Regional Universitario de Malaga
  • Santiago De Compostela, Spain
    • Hospital Clinico Universitario de Santiago
  • Tarragona, Spain
    • Hospital Universitario Joan XXIII de Tarragona
• Taiwan
  • Hsinchu, Taiwan
    • HsinChu MacKay Memorial Hospital
  • Kaohsiung, Taiwan
    • Chang Gung Memorial Hospital - Kaohsiung Branch
  • Taichung, Taiwan
    • Chung Shan Medical University Hospital
  • Taipei, Taiwan
    • Taipei Mackay Memorial Hospital
  • Taipei
    • Taipei city, Taipei, Taiwan, 100229
      • National Taiwan University Hospital
  • Taoyuan
    • Taoyuan City, Taoyuan, Taiwan, 333
      • Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation
• United Kingdom
  • London, United Kingdom, SW17 0QT
    • St. George's University Hospitals NHS Foundation Trust
  • Sheffield, United Kingdom
    • Sheffield Children's NHS Foundation Trust
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Nottingham University Hospitals NHS Trust
• United States
  • California
    • Long Beach, California, United States, 90806
      • Memorial Care Miller Children's and Women's Hospital
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles (UCLA)
    • Sacramento, California, United States, 95817
      • University of California Davis
  • Florida
    • Orlando, Florida, United States, 32827
      • Nemours Children's Hospital
    • Tampa, Florida, United States, 33606
      • South Tampa Center for Advanced Healthcare
  • Idaho
    • Rexburg, Idaho, United States, 83440
      • Rexburg Pediatrics
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Children's Research Institute
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • MedPharmics - Lafayette
    • Shreveport, Louisiana, United States, 71101
      • LSU Health
    • Shreveport, Louisiana, United States, 71103
      • Willis-Knighton Health System
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital - Division of Adolescent/Youth Adult Medicine
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Le Bonheur Children's Hospital
  • Texas
    • Corpus Christi, Texas, United States, 78411
      • Driscoll Children's Hospital
    • Dallas, Texas, United States, 75207
      • Children's Health Specialty Center Dallas Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

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 for Part 1 and ≤5 days for Part 2 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
• Subjects whose mother received an investigational RSV vaccination while pregnant with the subject if they were born at term (≥37 weeks of gestation) and are less than 12 months of age
• In Part 2, subjects dosed with an investigational or approved medication that is intended to prevent or treat RSV infection within the following times before the first dose of study drug: ribavirin 35 days; palivizumab 100 days; nirsevimab 350 days; other RSV-specific monoclonal antibody 5 half-lives of the specific antibody; RSV vaccines 12 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Concentrations of EDP-938 in Plasma	Plasma concentrations of EDP-938 were assessed at the designated time points.	3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5
Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)	TEAEs were defined as any event, side effect, or untoward medical occurrence in a participant enrolled in a clinical study whether or not it was considered to have a causal relationship to the study drug and first occurred or worsened during the post-baseline phase compared to baseline. Clinically significant changes from baseline in vital signs and clinical laboratory results were reported as TEAEs.	Day 1 to Day 28
Part 2: Model-Adjusted Daily Change From Baseline in Respiratory Syncytial Virus (RSV) Shedding in Nasal Swab Samples	Daily change from baseline in RSV shedding was defined as the daily change from baseline in RSV ribonucleic acid (RNA) viral load and was measured using reverse transcription-quantitative polymerase chain reaction (RT-qPCR) from nasal swabs. The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by Day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation is used to estimate the denominator degrees of freedom.	Baseline and pre-dose on Days 3, 5, 9, and 14
Pooled Population: Model-Adjusted Daily Change From Baseline in RSV Shedding in Nasal Swab Samples	Daily change from baseline in RSV shedding was defined as the daily change from baseline in RSV RNA viral load and was measured using RT-qPCR from nasal swabs. The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by Day interaction term as factors. An unstructured covariance matrix was imposed.The Satterthwaite approximation is used to estimate the denominator degrees of freedom.	Baseline and pre-dose on Days 3, 5, 9, and 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 and Part 2: Area Under the Curve (AUC) for RSV RNA Viral Load	The RSV RNA viral load was measured using RT-qPCR from nasal swabs. The AUC was calculated using the trapezoid rule. The AUC was calculated based on all available assessments collected on Days 1, 3, 5, 9 and 14 and the actual date/time of each assessment was used for the calculation.	Pre-dose on Day 1 through pre-dose on Days 3, 5, 9 and 14
Pooled Population: AUC of Change From Baseline in RSV RNA Viral Load	The RSV RNA viral load was measured using RT-qPCR from nasal swabs. The AUC was calculated using the trapezoid rule. The AUC was calculated based on all available assessments collected on Days 1, 3, 5, 9 and 14 and the actual date/time of each assessment was used for the calculation. The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.	Baseline (Pre-dose on Day 1) through pre-dose on Days 3, 5, 9 and 14
Part 1 and Part 2: Percentage of Participants With RSV RNA Viral Load Below the Limit of Detection (LOD)	The RSV RNA viral load was measured using RT-qPCR from nasal swabs.	Pre-dose on Days 3, 5, 9 and 14
Pooled Population: Percentage of Participants With RSV RNA Viral Load Below the LOD	The RSV RNA viral load was measured using RT-qPCR from nasal swabs.	Pre-dose on Days 3, 5, 9 and 14
Part 1 and Part 2: Time to RSV RNA Viral Load Being Undetectable	Time to RSV RNA viral load being undetectable was calculated as: first date of RSV RNA viral load target not detected (TND) after which no further samples had detectable RSV RNA viral load - date of first dose.	Day 1 to Day 28
Pooled Population: Time to RSV RNA Viral Load Being Undetectable	Time to RSV RNA viral load being undetectable was calculated as: first date of RSV RNA viral load TND after which no further samples had detectable RSV RNA viral load - date of first dose.	Day 1 to Day 28
Part 2: Number of Participants Who Experienced a TEAE	TEAEs were defined as any event, side effect, or untoward medical occurrence in a participant enrolled in a clinical study whether or not it was considered to have a causal relationship to the study drug and first occurred or worsened during the post-baseline phase compared to baseline. Clinically significant changes from baseline in vital signs and clinical laboratory results were reported as TEAEs.	Day 1 to Day 28
Pooled Population: Number of Participants Who Experienced a TEAE	TEAEs were defined as any event, side effect, or untoward medical occurrence in a participant enrolled in a clinical study whether or not it was considered to have a causal relationship to the study drug and first occurred or worsened during the post-baseline phase compared to baseline. Clinically significant changes from baseline in vital signs and clinical laboratory results were reported as TEAEs.	Day 1 to Day 28
Part 2: Concentrations of EDP-938 in Plasma	Plasma concentrations of EDP-938 were assessed at the designated time points.	3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5
Pooled Population: Concentrations of EDP-938 in Plasma	Plasma concentrations of EDP-938 were assessed at the designated time points.	3 hours post-dose on Day 1 and pre-dose on Day 2 (hospitalized participants only), Day 3, and Day 5
Part 2: Time to First Hospital Discharge for Hospitalized Participants	Time to first discharge for participants who were hospitalized at randomization was calculated as: date/time of first discharge - date/time of first dose with conversion to days. For participants with continuous hospitalization, the last date of discharge from the continuous hospitalization was used.	Day 1 to Day 28
Pooled Population: Time to First Hospital Discharge for Hospitalized Participants	Time to first discharge for participants who were hospitalized at randomization was calculated as: date/time of first discharge - date/time of first dose with conversion to days. For participants with continuous hospitalization, the last date of discharge from the continuous hospitalization was used.	Day 1 to Day 28
Part 2: Time to Use of Oxygen for Hospitalized Participants Who Were Not Receiving Oxygen at the Time They Received the First Dose of Study Drug	For participants were were hospitalized at randomization, time to use of oxygen for hospitalization participants who were not receiving oxygen at the time they received the first dose of study drug was calculated as: first date/time of receiving oxygen - date/time of first dose of study drug with conversion to days.	Day 1 to Day 28
Pooled Population: Time to Use of Oxygen for Hospitalized Participants Who Were Not Receiving Oxygen at the Time They Received the First Dose of Study Drug	For participants were were hospitalized at randomization, time to use of oxygen for hospitalization participants who were not receiving oxygen at the time they received the first dose of study drug was calculated as: first date/time of receiving oxygen - date/time of first dose of study drug with conversion to days.	Day 1 to Day 28
Part 2: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug	The numerator in the percentage calculation was defined by the number of participants who developed a new requirement for oxygen supplementation or new increase in oxygen requirements after the first dose of study drug, based on the response of "yes" to the "Is this an increase of oxygen supplementation compared to previous use?" question on the Oxygen Supplementation case report form (CRF). The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.	Day 1 to Day 28
Pooled Population: Percentage of Hospitalized Participants Who Required Oxygen Supplementation or Had an Increased Oxygen Requirement After the First Dose of Study Drug	The numerator in the percentage calculation was defined by the number of participants who developed a new requirement for oxygen supplementation or new increase in oxygen requirements after the first dose of study drug, based on the response of "yes" to the "Is this an increase of oxygen supplementation compared to previous use?" question on the Oxygen Supplementation CRF. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.	Day 1 to Day 28
Part 2: Time to Mechanical Ventilation for Hospitalized Participants	Time to mechanical ventilation for participants who were hospitalized at randomization was calculated as: first date/time of mechanical ventilation - date/time of first dose of study drug with conversion to days. Participants who were on mechanical ventilation before their first dose of study drug were excluded from the analysis.	Day 1 to Day 28
Pooled Population: Time to Mechanical Ventilation for Hospitalized Participants	Time to mechanical ventilation for participants who were hospitalized at randomization was calculated as: first date/time of mechanical ventilation - date/time of first dose of study drug with conversion to days. Participants who were on mechanical ventilation before their first dose of study drug were excluded from the analysis.	Day 1 to Day 28
Part 2: Percentage of Hospitalized Participants Who Required Mechanical Ventilation	The numerator in the percentage calculation was defined by the number of participants who developed a new requirement for mechanical ventilation after the first dose of study drug. Participants on mechanical ventilation prior to the first dose of study drug were excluded from analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.	Day 1 to Day 28
Pooled Population: Percentage of Hospitalized Participants Who Required Mechanical Ventilation	The numerator in the percentage calculation was defined by the number of participants who developed a new requirement for mechanical ventilation after the first dose of study drug. Participants on mechanical ventilation prior to the first dose of study drug were excluded from analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.	Day 1 to Day 28
Part 2: Percentage of Hospitalized Participants Who Died During the Study	The percentage of hospitalized participants who died during the study included deaths from any cause. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.	Day 1 to Day 28
Pooled Population: Percentage of Hospitalized Participants Who Died During the Study	The percentage of hospitalized participants who died during the study included deaths from any cause. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.	Day 1 to Day 28
Part 2: Time to Hospitalization for Initial Outpatients Who Were Subsequently Hospitalized	Time to hospitalization for initial outpatients who are not hospitalized at randomization but subsequently hospitalized was calculated as: first date/time of hospitalization - date/time of first dose with conversion to days.	Day 1 to Day 28
Pooled Population: Time to Hospitalization for Initial Outpatients Who Were Subsequently Hospitalized	Time to hospitalization for initial outpatients who are not hospitalized at randomization but subsequently hospitalized was calculated as: first date/time of hospitalization - date/time of first dose with conversion to days.	Day 1 to Day 28
Part 2: Percentage of Outpatients Who Were Subsequently Hospitalized or Died	Participants who were hospitalized at randomization were excluded from the analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.	Day 1 to Day 28
Pooled Population: Percentage of Outpatients Who Were Subsequently Hospitalized or Died	Participants who were hospitalized at randomization were excluded from the analysis. The 95% confidence interval was reported using the Clopper Pearson confidence interval methods.	Day 1 to Day 28
Part 2: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized	Resolution of symptoms was defined as the first of 2 consecutive timepoints where each of the seven symptoms assessed by the Parent/Caregiver Respiratory Syncytial Virus (RSV) Foundation (ReSVinet) score was 0 (not present) or 1 (mild). Time to resolution of symptoms for outpatients who were not hospitalized was calculated as: first date/time of resolution of symptoms - date/time of first dose with conversion to days. Participants who did not achieve resolution and had not been followed through the Day 14 visit or completed the Day 14 questionnaire were censored at Day 14. During the study, the parent(s)/caregiver(s) assessed the severity of RSV-related signs and symptoms. The ReSVinet assessed 7 symptoms, with each symptom being rated from 0 (not present) to 3 (severe), apart from fever which was scored from 0-2. The full range was 0 to 20 with higher scores representing more severe disease.	Day 1 to Day 14
Pooled Population: Time to Resolution of Symptoms for Outpatients Who Were Not Hospitalized	Resolution of symptoms was defined as the first of 2 consecutive timepoints where each of the seven symptoms assessed by the Parent/Caregiver ReSVinet score was 0 (not present) or 1 (mild). Time to resolution of symptoms for outpatients who were not hospitalized was calculated as: first date/time of resolution of symptoms - date/time of first dose with conversion to days. Participants who did not achieve resolution and had not been followed through the Day 14 visit or completed the Day 14 questionnaire were censored at Day 14. During the study, the parent(s)/caregiver(s) assessed the severity of RSV-related signs and symptoms. The ReSVinet assessed 7 symptoms, with each symptom being rated from 0 (not present) to 3 (severe), apart from fever which was scored from 0-2. The full range was 0 to 20 with higher scores representing more severe disease.	Day 1 to Day 14
Part 1: Daily Change From Baseline in RSV Shedding in Nasal Swab Samples	Daily change from baseline in RSV shedding in nasal swab samples was defined as the absolute daily change from baseline in RSV RNA viral load and measured using RT-qPCR from nasal swabs.	Baseline to pre-dose on Days 3, 5, 9, and Day 14

Collaborators and Investigators

• Sponsor: Enanta Pharmaceuticals, Inc
• Investigators: Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Actual): August 19, 2024
• Study Completion (Actual): August 19, 2024

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Respiratory Syncytial Virus, RSV, Pediatric study
• Other Study ID Numbers: EDP 938-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No