Clinical trial NCT04196101
Conditions: Respiratory Syncytial Virus
Keywords: RSV
Sponsor: Enanta Pharmaceuticals, Inc
Start date: 2020-01-22; Completion date: 2022-01-04
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a randomized, double-blind, placebo-controlled, multicentre, phase 2 study to evaluate the efficacy, safety and tolerability of orally administered EDP-938 in adults with RSV infection.

Detailed description:
Subjects (aged 18 to 75 years, inclusive) with up to 48 hours of upper respiratory tract infection (URTI) symptoms who tested positive for respiratory syncytial virus (RSV) and negative for influenza virus by rapid testing (ie, Rapid Viral Screen). Subjects with stable asthma or chronic obstructive pulmonary disease (COPD) were allowed in the study.

Eighty-two (82) subjects were enrolled in this Phase 2b, randomized, double-blind, placebo-controlled, multicentre study of EDP-938 administered orally for the treatment of acute URTI with confirmed RSV infection in ambulatory adult subjects.

For each subject, the duration of study participation was approximately 2 weeks and consisted of 3 periods: Screening (occurs on Day1), Treatment (5 days), and Follow-up (9 days after last dose).

Arms: arm 1: Subjects will take EDP-938 tablets (800 mg) once a day orally for 5 days arm 2: Subjects will take EDP-938 matching placebo tablets once a day orally for 5 days
Interventions: intervention 1: EDP-938 intervention 2: Placebo
Intervention descriptions: intervention 1: Four tablets daily for 5 days intervention 2: Four tablets daily for 5 days

Protocol documents:
SAP_002.pdf: 































































Prot_000.pdf: 
 
________________________________________________________________________________________________________ 
 
 
 
Clinical Study Protocol 
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF EDP-938 
ADMINISTERED ORALLY FOR THE TREATMENT OF ACUTE UPPER RESPIRATORY 
TRACT INFECTION WITH RESPIRATORY SYNCYTIAL VIRUS IN AMBULATORY 
ADULT SUBJECTS (RSVP) 
Protocol Number: EDP 938-102 
 
EudraCT number: 
2020-001529-30 
IND number 
135874 
 
 
ClinicalTrials.gov 
NCT04196101 
 
 
Protocol Version:
5.0 (Amendment 4.0, Global)
Date: 
Amendment 4.0 (Global): 20 May 2020 
Amendment 3.0 (Republic of South Africa Only): 11 Jan 2020 
Amendment 2.0 (Australia Only): 10 Jan 2020 
Amendment 1.0 (New Zealand Only): 09 Jan 2020 
Original Protocol: 10 Sep 2019 
 
 
Study Sponsor: 
Enanta Pharmaceuticals, Inc. 
500 Arsenal St. 
Watertown, MA 02472 
 
 
Sponsor Medical 
Monitor: 
 
Enanta Pharmaceuticals, Inc. 
500 Arsenal St. 
Watertown, MA 02472 
  
CONFIDENTIAL 
Information and data in this protocol contain trade secrets and privileged or confidential 
information, which is the property of Enanta Pharmaceuticals, Inc. No person is authorized to 
make it public without the written permission of Enanta Pharmaceuticals, Inc.  








Clinical Study Protocol  
EDP 938-102 v5.0 (Amendment 4.0) 
 
Enanta Pharmaceuticals, Inc. 
CONFIDENTIAL 
 
 
Page 5 of 79 
 
 
SIGNATURE PAGE 
The signature below constitutes the approval of this protocol and the attachments and provides 
the necessary assurances that this study will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable US federal regulations and International Council for 
Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines. 
 
 
Principal Investigator: 
___________________________________________________________ 
 
Signature: ____________________________ 
Date: 
_______________ 
 
 


Clinical Study Protocol  
EDP 938-102 v5.0 (Amendment 4.0) 
 
Enanta Pharmaceuticals, Inc. 
CONFIDENTIAL 
 
 
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TABLE OF CONTENTS 
CONTACT INFORMATION .................................................................................................................... 2 
SIGNATURE PAGE ................................................................................................................................... 5 
TABLE OF CONTENTS ........................................................................................................................... 6 
LIST OF TABLES .................................................................................................................................... 10 
LIST OF FIGURES .................................................................................................................................. 10 
LIST OF ABBREVIATIONS .................................................................................................................. 11 
PROTOCOL SUMMARY ....................................................................................................................... 13 
1. 
INTRODUCTION ....................................................................................................................... 24 
1.1 
OVERVIEW ....................................................................................................................................... 24 
1.2 
BACKGROUND ................................................................................................................................. 24 
1.3 
NONCLINICAL STUDIES .................................................................................................................... 24 
1.3.1 
Nonclinical Pharmacology ............................................................................................... 24 
1.3.2 
Nonclinical Pharmacokinetics .......................................................................................... 25 
1.3.3 
Safety Pharmacology ........................................................................................................ 25 
1.3.4 
Nonclinical Toxicology ..................................................................................................... 26 
1.4 
CLINICAL STUDIES ........................................................................................................................... 26 
1.5 
POTENTIAL RISKS AND BENEFITS .................................................................................................... 27 
2. 
OBJECTIVES AND ENDPOINTS ............................................................................................ 29 
2.1 
OBJECTIVES ..................................................................................................................................... 29 
2.1.1 
Primary Objective ............................................................................................................. 29 
2.1.2 
Secondary Objectives ........................................................................................................ 29 
 
 
2.2 
ENDPOINTS ...................................................................................................................................... 29 
2.2.1 
Primary Endpoint ............................................................................................................. 29 
2.2.2 
Secondary Endpoints ........................................................................................................ 29 
 
 
3. 
SELECTION OF SUBJECTS .................................................................................................... 31 
3.1 
SUBJECT INCLUSION CRITERIA ........................................................................................................ 31 
3.2 
SUBJECT EXCLUSION CRITERIA ....................................................................................................... 33 
4. 
STUDY DESIGN .......................................................................................................................... 36 
4.1 
DOSE AND TREATMENT SCHEDULE .................................................................................................. 36 
4.2 
RATIONALE FOR STUDY DESIGN ...................................................................................................... 37 
4.2.1 
Justification of Study Design, Endpoints, and Subject Population ................................... 37 
4.2.2 
Justification of EDP-938 Dose ......................................................................................... 38 
5. 
STUDY DRUG AND TREATMENT OF SUBJECTS ............................................................. 41 
5.1 
DESCRIPTION OF STUDY DRUG ........................................................................................................ 41 
5.2 
PACKAGING AND LABELING ............................................................................................................ 41 
5.3 
STORAGE ......................................................................................................................................... 41 


Clinical Study Protocol  
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5.4 
ACCOUNTABILITY ............................................................................................................................ 41 
5.5 
HANDLING AND DISPOSAL ............................................................................................................... 42 
5.6 
TREATMENT ASSIGNMENT/RANDOMIZATION .................................................................................. 42 
5.7 
STUDY DRUG DOSE AND ADMINISTRATION ..................................................................................... 43 
5.7.1 
Dispensing of Study Drug ................................................................................................. 43 
5.7.2 
Treatment Compliance ...................................................................................................... 43 
5.8 
CONCOMITANT MEDICATIONS ......................................................................................................... 44 
5.9 
PROHIBITED MEDICATIONS .............................................................................................................. 44 
6. 
BLINDING ................................................................................................................................... 46 
6.1 
UNBLINDING .................................................................................................................................... 46 
7. 
STUDY CONDUCT AND VISIT SCHEDULE ........................................................................ 47 
7.1 
STUDY SITE VISITS .......................................................................................................................... 47 
7.1.1 
Screening Period on Day 1 ............................................................................................... 47 
7.1.2 
Treatment Period (Days 1 to 5) ........................................................................................ 47 
7.1.3 
Follow-up Period (Days 6 to 14) ...................................................................................... 48 
7.2 
SUBJECT WITHDRAWAL/EARLY TERMINATION ............................................................................... 49 
7.2.1 
Withdrawal Criteria .......................................................................................................... 49 
7.2.2 
Procedures for Early Discontinuation or Early Termination of Treatment ..................... 50 
7.2.3 
Documentation of Withdrawal of Subjects........................................................................ 50 
8. 
STUDY PROCEDURES/EVALUATIONS ............................................................................... 51 
8.1 
TIMING OF ASSESSMENTS ................................................................................................................ 51 
8.2 
DEMOGRAPHICS AND MEDICAL HISTORY ........................................................................................ 51 
8.2.1 
Prior and Concomitant Medications ................................................................................ 51 
8.3 
CLINICAL EVALUATIONS ................................................................................................................. 51 
8.3.1 
Vital Sign Measurements .................................................................................................. 51 
8.3.2 
Electrocardiograms .......................................................................................................... 51 
8.3.3 
Physical Examination ....................................................................................................... 52 
8.3.4 
Height, Weight, and Body Mass Index .............................................................................. 52 
8.3.5 
Adverse Events .................................................................................................................. 52 
8.3.6 
Pulse Oximetry.................................................................................................................. 52 
8.3.7 
Frailty Scale Score ........................................................................................................... 53 
8.3.8 
Respiratory Syncytial Virus Symptom Diary .................................................................... 53 
 
 
8.3.10 
Collection of Nasal and Nasopharyngeal Swabs and Blood Samples .............................. 53 
8.4 
LABORATORY AND DIAGNOSTIC PROCEDURES ................................................................................ 54 
8.4.1 
Routine Laboratory Panels ............................................................................................... 54 
8.4.2 
Pregnancy and Menopausal Laboratory Testing .............................................................. 54 
8.5 
VIROLOGY ASSESSMENTS ................................................................................................................ 56 
8.5.1 
Respiratory Syncytial Virus, Influenza, and SARS-CoV-2 Rapid Molecular 
Diagnostic Tests................................................................................................................ 56 
8.5.2 
Confirmatory Respiratory Pathogen Panel ...................................................................... 56 
8.5.3 
Respiratory Syncytial Virus RNA Quantification of Viral Load ....................................... 57 
8.5.4 
Respiratory Syncytial Virus Subgroup (A or B) Determination ........................................ 57 
 
 
8.5.6 
Respiratory Syncytial Virus Serology ............................................................................... 57 
8.6 
PHARMACOKINETIC SAMPLES .......................................................................................................... 57 


Clinical Study Protocol  
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9. 
SAFETY MONITORING AND REPORTING ........................................................................ 59 
9.1 
DEFINITIONS .................................................................................................................................... 59 
9.1.1 
Pretreatment Events .......................................................................................................... 59 
9.1.2 
Adverse Events .................................................................................................................. 59 
9.1.3 
Serious Adverse Events ..................................................................................................... 59 
9.2 
DOCUMENTING AND REPORTING OF ADVERSE EVENTS (INCLUDING SERIOUS ADVERSE 
EVENTS) .......................................................................................................................................... 60 
9.2.1 
Documenting and Reporting Adverse Events .................................................................... 60 
9.2.2 
Assigning Attribution of Adverse Events ........................................................................... 61 
9.2.3 
Classifying Action Taken With Study Drug ....................................................................... 62 
9.2.4 
Classifying Adverse Event Outcome ................................................................................. 62 
9.2.5 
Documenting and Reporting Serious Pretreatment Events and Serious Adverse 
Events................................................................................................................................ 63 
9.2.6 
Documenting and Reporting of Pregnancy ....................................................................... 64 
9.3 
FOLLOW-UP OF ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ............................................... 64 
9.4 
SPONSOR’S REVIEW OF ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ................................... 64 
9.5 
DATA SAFETY MONITORING BOARD ............................................................................................... 64 
10. 
SUBJECT SAFETY MANAGEMENT/ STUDY STOPPING RULES .................................. 65 
10.1 
STUDY STOPPING RULES .................................................................................................................. 65 
10.2 
SITE OR STUDY DISCONTINUATION .................................................................................................. 65 
10.2.1 
Study Discontinuation ....................................................................................................... 65 
10.2.2 
Site Termination................................................................................................................ 65 
10.2.3 
Study Termination Procedures ......................................................................................... 66 
11. 
STATISTICAL CONSIDERATIONS ....................................................................................... 67 
11.1 
GENERAL CONSIDERATIONS ............................................................................................................ 67 
 
 
11.3 
ANALYSIS POPULATIONS ................................................................................................................. 67 
11.4 
SUBJECT DISPOSITION AND DEMOGRAPHIC DATA ........................................................................... 68 
11.5 
METHOD OF TREATMENT ASSIGNMENT ........................................................................................... 68 
11.6 
EFFICACY ANALYSES ....................................................................................................................... 68 
11.6.1 
Primary Efficacy Analyses ................................................................................................ 68 
11.6.2 
Secondary Efficacy Analyses ............................................................................................ 69 
11.7 
SAFETY ANALYSES .......................................................................................................................... 69 
11.7.1 
Treatment Compliance ...................................................................................................... 69 
11.7.2 
Adverse Events .................................................................................................................. 69 
11.7.3 
Clinical Laboratory Data ................................................................................................. 70 
11.7.4 
Vital Sign Measurements .................................................................................................. 70 
11.7.5 
Electrocardiograms .......................................................................................................... 71 
11.7.6 
Pulse Oximetry.................................................................................................................. 71 
11.7.7 
Concomitant Medications ................................................................................................. 71 
11.7.8 
Physical Examinations ...................................................................................................... 71 
11.8 
PHARMACOKINETIC ANALYSES ....................................................................................................... 71 
11.9 
SUBGROUP AND COVARIATE ANALYSES .......................................................................................... 71 
 
 
11.11 
INTERIM ANALYSES ......................................................................................................................... 72 


Clinical Study Protocol  
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12. 
STUDY ADMINISTRATION ..................................................................................................... 73 
12.1 
ETHICAL CONSIDERATIONS ............................................................................................................. 73 
12.1.1 
Ethical Conduct of the Study ............................................................................................ 73 
12.1.2 
Ethical Review .................................................................................................................. 73 
12.1.3 
Written Informed Consent ................................................................................................. 73 
12.1.4 
Investigator Compliance ................................................................................................... 74 
12.2 
DATA COLLECTION .......................................................................................................................... 74 
12.3 
STUDY MONITORING ....................................................................................................................... 74 
12.4 
QUALITY ASSURANCE ..................................................................................................................... 75 
12.5 
RETENTION OF RECORDS ................................................................................................................. 75 
12.6 
INFORMATION DISCLOSURE ............................................................................................................. 75 
12.6.1 
Confidentiality .................................................................................................................. 75 
12.6.2 
Publication Policy ............................................................................................................ 76 
13. 
REFERENCES ............................................................................................................................. 77 
14. 
APPENDICES .............................................................................................................................. 78 
APPENDIX 1: 
SCHEDULE OF ASSESSMENTS ............................................................................................. 78 


Clinical Study Protocol 
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LIST OF TABLES 
Table 1: 
List of Clinical Studies With EDP-938 ............................................................................. 27 
Table 2: 
Clinical and Respiratory Syncytial Virus Laboratory Evaluations ................................... 55 
Table 3: 
Options for Action Taken With Study Drug ..................................................................... 62 
Table 4:  
Classification and Definition of Adverse Event Outcomes .............................................. 63 
 LIST OF FIGURES 
Figure 1: Study Design ............................................................................................................................... 36 
 


Clinical Study Protocol 
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LIST OF ABBREVIATIONS 
AE 
adverse event 
ATC 
Anatomical Therapeutic Chemical 
AUC 
area under the curve 
AUC0-24 
area under the curve from 0 to 24 hours 
AUC0-inf 
area under the curve from 0 to infinity 
ALRI 
acute lower respiratory illness 
ANCOVA 
analysis of covariance 
BMI 
body mass index 
CFR 
Code of Federal Regulations 
CI 
confidence intervals 
COPD 
chronic obstructive pulmonary disease 
Ctrough 
trough concentration 
CYP 
cytochrome P450 
DSMB 
Data Safety Monitoring Board 
EC 
ethics committee 
EC50 
half-maximal effective concentration 
EC90 
90% maximal effective concentration 
ECG 
electrocardiogram 
eCOA 
electronic clinical outcome assessment 
eCRF 
electronic case report form 
EOS 
end-of-study 
EOT 
end-of-treatment 
FDA 
Food and Drug Administration 
FEV1 
forced expiratory volume in 1 second 
FIH 
first-in-human 
 
 
FSH 
follicle-stimulating hormone 
FVC 
forced vital capacity 
GCP 
Good Clinical Practice 
GINA 
Global Initiative for Asthma 
HDPE 
high-density polyethylene 
IC50 
half-maximal inhibitory concentration 
ICF 
informed consent form 
ICH 
International Council for Harmonisation  
IRB 
institutional review board 
IWRS 
Interactive Web Response System 
LD 
loading dose 


Clinical Study Protocol 
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LLN 
lower limit of normal 
mITT 
Modified Intent-to-Treat 
MCMC 
Markov Chain Monte Carlo 
N 
nucleoprotein 
NCI-CTCAE 
National Cancer Institute Common Terminology Criteria for Adverse Events 
PK 
pharmacokinetic(s) 
PND 
postnatal day 
PP 
Per Protocol 
QTcF 
QT interval corrected for heart rate according to Fridericia 
RSV 
respiratory syncytial virus 
RT-qPCR 
quantitative reverse transcription polymerase chain reaction 
SAE 
serious adverse event 
SAF 
Safety (for the analysis population) 
SAP 
statistical analysis plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SoA 
Schedule of Assessments 
SPM  
Study Procedures Manual 
TEAE 
treatment-emergent adverse event 
TSS 
total symptom score 
ULN 
upper limit of normal 
URTI 
upper respiratory tract infection 
WHO 
World Health Organization 


Protocol Synopsis  
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PROTOCOL SUMMARY 
Name of Sponsor/Company: Enanta Pharmaceuticals, Inc. 
Name of Investigational Product: EDP-938 
Study Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of EDP-938 
Administered Orally for the Treatment of Acute Upper Respiratory Tract Infection with 
Respiratory Syncytial Virus in Ambulatory Adult Subjects (RSVP) 
Protocol Number: EDP 938-102 
Phase of Development: 2b 
Study Centers: This will be a multicenter global study and may include sites in North America, 
South America, Africa, Australia/New Zealand, and Europe. 
Number of Subjects Planned: Approximately 70 subjects will be enrolled. 
Planned Study Population: Ambulatory, nonhospitalized subjects (aged 18 to 75 years, 
inclusive) with up to 48 hours of upper respiratory tract infection (URTI) symptoms who test 
positive for respiratory syncytial virus (RSV) and negative for influenza virus by rapid testing 
(ie, Rapid Viral Screen). Subjects with stable asthma or chronic obstructive pulmonary disease 
(COPD) will be allowed in the study. 
Investigational Product, Dosage, and Mode of Administration: EDP-938 will be supplied as 
tablets for oral administration 
: 
 200 mg. The total dose 
administered will be 800 mg of EDP-938 or placebo once daily for 5 days. 
Duration of Treatment: 5 days 
Study Objectives: 
Primary Objective 
• To evaluate the effect of EDP-938 on the progression of RSV infection by assessment of 
clinical symptoms  
Secondary Objectives 
• To evaluate the antiviral efficacy of EDP-938  
• To evaluate the pharmacokinetics (PK) of EDP-938  
• To evaluate the safety of EDP-938  


Protocol Synopsis  
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Exploratory Objectives  
• To evaluate EDP-938 in terms of emergence of viral resistance 
• To evaluate the relationship between the PK of EDP-938 and antiviral activity and 
clinical symptoms 
• To explore the progression of RSV infection using the 
 
 
• To evaluate the relationship between RSV subgroup A or B with antiviral and clinical 
efficacy of EDP-938 
Criteria for Evaluation:  
Primary Endpoint 
• Effect of EDP-938 compared to placebo on RSV infection clinical symptoms measured as 
the total symptom score (TSS) area under the curve (AUC) from Day 1 through Day 14 
Secondary Endpoints 
• The AUC for RSV RNA viral load measured in nasopharyngeal swab samples by 
quantitative reverse transcription polymerase chain reaction (RT-qPCR) 
• Percentage of subjects with RSV RNA viral load below the lower limit of quantitation in 
subjects receiving EDP-938 compared to placebo 
• Plasma PK concentrations of EDP-938 
 
 
 
• Safety endpoints include, but are not limited to, adverse events (AEs), vital sign 
measurements, pulse oximetry measurements, and clinical laboratory test results 
(including chemistry, hematology, and urinalysis) 
• Time to RSV RNA viral load below the lower limit of quantitation in subjects receiving 
EDP-938 compared to placebo 
• RSV RNA viral load change from Baseline 
  
 
 
 
 
 
 
 
  
Study Design: 
This is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study of EDP-938 
administered orally for the treatment of acute URTI with confirmed RSV infection in ambulatory 
adult subjects.  




Protocol Synopsis  
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dose, and the device should be brought to each study site visit. In case the subject is unable to 
complete any assessments or recordings into the device for technical reasons, the subject will also 
be provided with a paper diary(ies) as a back-up. 
The subject will be instructed on the use of concomitant medications during the study, including 
the use of acetaminophen as the study-specific analgesic/antipyretic (see Section 5.8 and 
Section 5.9). 
Subjects will receive the first dose of study drug while at the study site. After the first dose, 
subjects will be instructed to take 800 mg of EDP-938 or placebo once daily at approximately the 
same time every day (±1 hour) on each of the 4 subsequent days. The subject will also receive 
instruction on the appropriate storage and transport of study drug.  
On Day 3 and Day 5 (end-of-treatment), subjects should bring their study drug with them as part 
of their study site visit (in the provided cooler system) for drug accountability and for dosing of 
study drug on Day 5. If a subject is unable to attend the Day 3 and/or Day 5 study site visit, a 
home visit by a study nurse may be arranged, if feasible; refer to the Study Procedures Manual 
(SPM) for details. 
Subjects who discontinue treatment early (ie, prior to completing 5 days of dosing) should return 
to the study site within 24 hours and no more than 48 hours later to complete the end-of-study 
(EOS) procedures.  
All study assessments during the Treatment Period, including PK sample collection, are detailed 
in the SoA. 
Follow-up Period (Days 6 to 14): Subjects should return to the study site for follow-up visits on 
Day 9 and Day 14 (EOS Visit) for post-treatment safety assessments. Visit assessments may be 
completed at the study site or by a study nurse via a home visit, if feasible; refer to the SPM for 
details. 
Subjects who discontinue the study early (ie, prior to Day 14) should return to the study site 
within 24 hours and no more than 48 hours later to complete the EOS procedures.  
All study assessments during the Follow-up Period are detailed in the SoA. 
Throughout the study, safety for each subject in each study period will be evaluated by 
assessment of clinical laboratory findings, physical examination findings (as applicable), vital 
sign measurements, pulse oximetry measurements (only for subjects with asthma or COPD), and 
AEs. 


Protocol Synopsis  
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Study Design Figure: 
 
Abbreviations: d = day; FLU = influenza virus; RSV = respiratory syncytial virus. 
Eligibility Criteria 
Inclusion Criteria 
Each subject must meet all of the following criteria to be enrolled into this study: 
1. A full ICF signed and dated by the subject. (Note: Prior to signing the full ICF, subjects 
will sign a Rapid Viral Screen ICF as described in inclusion criterion #4.) 
2. Male or female individuals aged 18 to 75 years, inclusive. 
3. Up to 48 hours of URTI symptoms with at least one of the following symptoms:  
Nasal discharge, nasal congestion, malaise/tiredness, headache, sinus congestion, 
sneezing, sore throat, hoarseness, cough, shortness of breath, respiratory wheeze, earache, 
and/or symptoms of fever. 
Note: The duration of symptoms (not more than 48 hours) is to be measured from the 
estimated time of onset of the first symptom. 
4. After signing the Rapid Viral Screen ICF, positive for RSV infection and negative for 
influenza virus based on rapid diagnostic screen of nasal (or nasopharyngeal) swab 
samples. 
5. Medically stable based on assessment of physical examination, medical history, vital sign 
measurements, pulse oximetry (only for subjects with asthma or COPD), and 12-lead 
ECG performed at Screening. 
6. A body mass index ≥18 kg/m2 and ≤40 kg/m2. 
7. Negative urine pregnancy test for women of childbearing potential as defined in 
inclusion criterion #8. 


Protocol Synopsis  
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8. A woman of childbearing potential who is sexually active with a male must agree to use 
two effective methods of contraception from the date of Screening until 30 days after her 
last dose of study drug. Effective methods of contraception are defined as: 
A condom for the male partner and at least one of the following for the female subject: 
a. Intrauterine device 
b. Occlusive cap (diaphragm or cervical/vault caps) 
c. Oral, injectable, implantable, transdermal, or intravaginal hormonal contraceptive 
Note: The above does not apply to a female subject who has a vasectomized male as the 
sole partner or who is of nonchildbearing potential (ie, physiologically incapable of 
becoming pregnant) as defined below: 
a. Has had a complete hysterectomy ≥3 months prior to dosing or 
b. Has had a bilateral oophorectomy (ovariectomy) or 
c. Has had a bilateral tubal ligation or fallopian tube inserts or 
d. Is postmenopausal (a total cessation of menses for at least 2 years; Note: Subjects 
with a cessation of menses between 1 to 2 years and a follicle-stimulating hormone 
[FSH] level of >35 mIU/mL will also be considered to be postmenopausal). 
9. A male subject who has not had a vasectomy and is sexually active with a woman of 
childbearing potential must agree to use effective contraception from the date of 
Screening to 90 days after his last dose of study drug. Effective contraception is defined 
as a condom and at least one of the following for a female partner: 
a. Intrauterine device 
b. Occlusive cap (diaphragm or cervical/vault caps) 
c. Oral, injectable, implantable, transdermal, or intravaginal contraceptive 
Note: For a male subject who has had a vasectomy, use of a condom will still be required. 
10. Male subjects must agree to refrain from sperm donation from the date of Screening until 
90 days after his last dose of study drug. 
11. Must be willing and able to adhere to the study assessments, visit schedules, prohibitions, 
and restrictions, as described in this protocol. 
Additional Inclusion Criteria for Subjects With Asthma 
12. Physician-diagnosed asthma and currently receiving Global Initiative for Asthma (GINA) 
Step 2, 3, or 4 treatment, with stable dosing for at least 4 weeks prior to Screening.  
13. Stable prebronchodilator forced expiratory volume in 1 second (FEV1) ≥60% of predicted 
within the prior 12 months of Screening based on historical spirometry medical records.  


Protocol Synopsis  
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Additional Inclusion Criteria for Subjects With COPD 
14. Physician-diagnosed COPD and currently receiving either short-acting bronchodilators 
(as required) or up to two maintenance therapies.  
15. No change in the background COPD therapy for at least 4 weeks prior to Screening. 
16. Stable postbronchodilator FEV1 >50% of predicted and FEV1:forced vital capacity (FVC) 
ratio <0.7 within the prior 12 months of Screening based on historical spirometry medical 
records. 
Exclusion Criteria  
Subjects will not be eligible to participate in the study if they meet any of the following criteria: 
1. Clinical evidence of a lower respiratory tract infection, as determined by the Investigator. 
2. Anticipated need for hospitalization or emergency room care within 24 hours of 
Screening. 
3. Receipt of systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy 
within 7 days of Screening and for the duration of the study. 
4. Awareness of concomitant respiratory infections that are viral (other than RSV), bacterial, 
or fungal, including systemic bacterial or fungal infections, within 7 days of Screening. 
5. SARS-CoV-2 positive within 28 days of Screening or at Screening following signature of 
full ICF. 
6. Frailty scale score ≥4 at Screening. 
7. History of chronic liver disease (eg, hemochromatosis, Wilson’s disease, alpha-1 
antitrypsin deficiency, autoimmune hepatitis, nonalcoholic steatohepatitis, and/or 
alcoholic liver disease); a history of biliary disease (eg, primary sclerosing cholangitis, 
cholecystitis, choledocholithiasis); or a history of portal hypertension. A diagnosis of 
hepatic steatosis (fatty liver) is not exclusionary. 
8. Heart disease: any congenital heart disease, acute or chronic heart failure, ischemic heart 
disease, congenital long QT syndrome, or any clinical manifestation resulting in QT 
interval prolongation. Note: Subjects with controlled hypertension without cardiac 
compromise will be allowed to enroll. See exclusion criterion #18 for prohibited 
medications. 
9. Neurological and neurodevelopmental disorders (including disorders of the brain, spinal 
cord, peripheral nerve, and muscle, eg, cerebral palsy, epilepsy [seizure disorders], stroke, 
muscular dystrophy, or spinal cord injury). Note: Minor neurological disorders (eg, past 
concussions, headaches, migraine) are allowed. 
10. Malignant tumor or history of malignancy that may interfere with the aims of the study or 
a subject completing the study. 
11. Prior receipt or the subject is waiting to receive a bone marrow, stem cell, or solid organ 
transplantation.  


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12. Diagnosis of cystic fibrosis. 
13. Known positive human immunodeficiency virus, active hepatitis A virus infection, 
chronic hepatitis B virus infection, and/or current or treated hepatitis C virus infection. 
14. Prior or planned ileal resection or bariatric surgery. Note: Subjects who have undergone 
gastric surgeries that do not affect drug absorption (eg, gastric band or gastric sleeve 
procedures) will be allowed to participate if they are stable for at least 1 year prior to 
Screening. Gastrectomy will be allowed if stable for at least 3 years prior to Screening. 
15. Pregnant or nursing female subjects. 
16. History of alcohol addiction or current heavy alcohol use defined as: >14 standard drinks 
per week and/or ≥4 standard drinks per occasion for males and >7 standard drinks per 
week and/or ≥3 standard drinks per occasion for females. A standard drink is 12 oz of 
beer (5% alcohol), 5 oz table wine (12% alcohol), or 1.5 oz of spirits (40% alcohol).  
17. Known or suspected, in the opinion of the Investigator, renal disease or renal impairment. 
18. Twelve-lead ECG demonstrating a QT interval corrected for heart rate according to 
Fridericia (QTcF) that is >500 msec or other clinically relevant abnormalities as judged 
by the Investigator at Screening. 
19. Use of or intention to use excluded or contraindicated medication(s) or supplements, 
including any medication known to be a moderate or potent inducer or inhibitor of the 
cytochrome P450 3A4 enzyme, within 14 days prior to Screening and for the duration of 
the study. 
20. Receipt of ≥14 days of systemic immunomodulator therapy (eg, oral corticosteroids) 
within 3 months of Screening. 
21. Prior to the first dose of study drug and during study participation, the subject has 
received any vaccine, investigational agent, or biological product within 30 days or 
5 times the half-life, whichever is longer. Note: Influenza vaccination within 7 days of 
Screening is not allowed. 
22. Use of St John’s wort within 28 days prior to the first dose of study drug and for the 
duration of the study. 
23. History of or currently experiencing a medical condition or any other finding (including 
laboratory test results) that, in the opinion of the Investigator, might confound the results 
of the study; pose an additional risk in administering study drug to the subject; could 
prevent, limit, or confound the protocol-specified assessments; or deems the subject 
unsuitable for the study.  


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Additional Exclusion Criteria for Subjects With Asthma  
24. Subjects must not have experienced a severe asthma exacerbation (defined as worsening 
asthma that requires treatment with oral corticosteroids for 3 or more days, or emergency 
room attendance) or deterioration in asthma requiring an increase in asthma treatment for 
at least 6 weeks prior to Screening. 
25. Subject is receiving more than two maintenance asthma therapies or theophylline 
preparations for asthma treatment. 
26. Pulse oximetry reading of <90% oxygen saturation measured at rest at Screening. 
Additional Exclusion Criteria for Subjects With COPD 
27. Receipt of theophylline, roflumilast, maintenance oral corticosteroids, or long-term 
oxygen therapy (defined as prescribed for 12 or more hours per day). 
28. Exacerbation of COPD requiring treatment with systemic corticosteroids and/or 
antibiotics, or emergency room attendance or hospitalization within 6 weeks prior to 
Screening.  
29. More than three COPD exacerbations with the past 12 months. 
30. Pulse oximetry reading of <90% oxygen saturation measured at rest at Screening. 
Subject Withdrawal: Subjects may be discontinued from the study at any time if the subject, 
Investigator, or Sponsor determines that it is not in the best interest of the subject to continue 
participation. Reasons for discontinuation include the following: 
• AE 
• Lack of efficacy 
• Lost to follow-up 
• Withdrawal by subject 
• Protocol deviation (including noncompliance with study drug or study procedures) 
• Pregnancy 
• Study terminated by the Sponsor 
• Other 
Statistical Methods: Detailed statistical analysis will be outlined in the statistical analysis plan, 
which will be developed and finalized prior to database lock.  
Sample Size Considerations: Using a ratio of 1:1, a sample size of 27 subjects per treatment 
group (54 subjects total) provides 80% power to detect a treatment reduction in TSS AUC of at 
least 55% from placebo (assuming TSS AUC from the previous Phase 2a clinical challenge study 
to: mean [standard deviation] of placebo: 500 [450] and EDP-938: 225 [200]) using a t-test with 


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Statistical Analysis: The following analysis populations are planned:  
Safety (SAF) Population: All subjects who receive at least one dose of study drug. Subjects will 
be analyzed in the treatment group that corresponds to the study drug received during the study. 
Modified Intent-to-Treat (mITT) Population: All subjects who receive at least one dose of study 
drug. Subjects will be analyzed as treated. The mITT Population is designated as the primary 
efficacy population. 
Per Protocol (PP) Population: All subjects who are randomized and receive all planned doses of 
study drug and do not have major protocol deviations that may unduly influence outcome. 
Subjects will be analyzed in the treatment group that corresponds to the study drug received 
during the study. 
Pharmacokinetic (PK) Population: All subjects receiving active study drug and having any 
measurable plasma concentration of study drug at any timepoint. 
Subject Disposition and Demographic Data: The number of subjects screened, randomized, and 
in the SAF, mITT, and PK Populations will be summarized using frequencies and percentages. 
Subject demographics will be summarized by treatment group for all subjects in the 
SAF Population. Appropriate baseline characteristics will be included in addition to demographic 
characteristics. 
Efficacy Analyses: The primary efficacy analysis will be performed on the TSS AUC. The TSS 
AUC is measured twice daily (before or after treatment, morning/evening) using the 13-point 
symptom scale. The AUC will be calculated using the trapezoid rule. The TSS will be compared 
between EDP-938 and placebo using an analysis of covariance (ANCOVA) model with treatment 
group and stratification factor as fixed effects and the baseline TSS as a covariate. Treatment 
groups will be compared using a type III sum-of-squares. The least-squares means and two-sided 
95% confidence intervals will be presented for individual groups and the difference between 
groups.  
Sensitivity analysis of the primary endpoint will be performed using the Markov Chain Monte 
Carlo method of multiple imputation. Following imputation, the TSS AUC will be calculated and 
an ANCOVA model with treatment group and stratification factor as fixed effects, and the 
baseline TSS as a covariate will be performed. Treatment groups will be compared using a 
type III sum-of-squares. Other sensitivity analysis may include a mixed model repeated measures 
analysis on the change from Baseline over all visits. 
The RSV RNA viral load AUC measured in nasopharyngeal swab samples by RT-qPCR will be 
measured on Days 1, 3, 5, 9, and 14. The trapezoid rule will be used to calculate the AUC of the 
RSV RNA viral load. An ANCOVA model with treatment group and stratification factor as fixed 
effects and the baseline RSV RNA viral load as a covariate will be performed. Treatment groups 
will be compared using a type III sum-of-squares. The proportion of subjects with RSV RNA 
below the lower limit of quantitation will be analyzed on Days 3, 5, 9, and 14. Treatment groups 
will be compared using a Cochran-Mantel-Haenszel test controlling for the stratification factor. 


















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3. 
SELECTION OF SUBJECTS 
A total of approximately 70 subjects are planned to be enrolled into this study. 
3.1 
Subject Inclusion Criteria 
Each subject must meet all of the following criteria to be enrolled into this study: 
1. A full informed consent form (ICF) signed and dated by the subject. (Note: Prior to 
signing the full ICF, subjects will sign a Rapid Viral Screen ICF as described in inclusion 
criterion #4.) 
2. Male or female individuals aged 18 to 75 years, inclusive. 
3. Up to 48 hours of upper respiratory tract infection (URTI) symptoms with at least one of 
the following symptoms:  
Nasal discharge, nasal congestion, malaise/tiredness, headache, sinus congestion, 
sneezing, sore throat, hoarseness, cough, shortness of breath, respiratory wheeze, earache, 
and/or symptoms of fever. 
Note: The duration of symptoms (not more than 48 hours) is to be measured from the 
estimated time of onset of the first symptom. 
4. After signing the Rapid Viral Screen ICF, positive for RSV infection and negative for 
influenza virus based on rapid diagnostic screen of nasal (or nasopharyngeal) swab 
samples.  
5. Medically stable based on assessment of physical examination, medical history, vital sign 
measurements, pulse oximetry (only for subjects with asthma or chronic obstructive 
pulmonary disease [COPD]), and 12-lead ECG performed at Screening. 
6. A body mass index (BMI) ≥18 kg/m2 and ≤40 kg/m2. 
7. Negative urine pregnancy test for women of childbearing potential as defined in inclusion 
criterion #8. 
8. A woman of childbearing potential who is sexually active with a male must agree to use 
two effective methods of contraception from the date of Screening until 30 days after her 
last dose of study drug. Effective methods of contraception are defined as: 
A condom for the male partner and at least one of the following for the female subject: 
a. Intrauterine device 
b. Occlusive cap (diaphragm or cervical/vault caps) 
c. Oral, injectable, implantable, transdermal, or intravaginal hormonal contraceptive 


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Note: The above does not apply to a female subject who has a vasectomized male as the 
sole partner or who is of nonchildbearing potential (ie, physiologically incapable of 
becoming pregnant) as defined below: 
a. Has had a complete hysterectomy ≥3 months prior to dosing or 
b. Has had a bilateral oophorectomy (ovariectomy) or 
c. Has had a bilateral tubal ligation or fallopian tube inserts or 
d. Is postmenopausal (a total cessation of menses for at least 2 years; Note: Subjects 
with a cessation of menses between 1 to 2 years and a follicle-stimulating hormone 
[FSH] level of >35 mIU/mL will also be considered to be postmenopausal). 
9. A male subject who has not had a vasectomy and is sexually active with a woman of 
childbearing potential must agree to use effective contraception from the date of 
Screening to 90 days after his last dose of study drug. Effective contraception is defined 
as a condom and at least one of the following for a female partner: 
a. Intrauterine device 
b. Occlusive cap (diaphragm or cervical/vault caps) 
c. Oral, injectable, implantable, transdermal, or intravaginal contraceptive 
Note: For a male subject who has had a vasectomy, use of a condom will still be required. 
10. Male subjects must agree to refrain from sperm donation from the date of Screening until 
90 days after his last dose of study drug. 
11. Must be willing and able to adhere to the study assessments, visit schedules, prohibitions, 
and restrictions, as described in this protocol. 
Additional Inclusion Criteria for Subjects With Asthma 
12. Physician-diagnosed asthma and currently receiving Global Initiative for Asthma (GINA) 
Step 2, 3, or 4 treatment, with stable dosing for at least 4 weeks prior to Screening.  
13. Stable prebronchodilator forced expiratory volume in 1 second (FEV1) ≥60% of predicted 
within the prior 12 months of Screening based on historical spirometry medical records. 
Additional Inclusion Criteria for Subjects With COPD 
14. Physician-diagnosed COPD and currently receiving either short-acting bronchodilators 
(as required) or up to two maintenance therapies.  
15. No change in the background COPD therapy for at least 4 weeks prior to Screening. 
16. Stable postbronchodilator FEV1 >50% of predicted and FEV1:forced vital capacity (FVC) 
ratio <0.7 within the prior 12 months of Screening based on historical spirometry medical 
records. 


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3.2 
Subject Exclusion Criteria 
Subjects will not be eligible to participate in the study if they meet any of the following criteria: 
1. Clinical evidence of a lower respiratory tract infection, as determined by the Investigator. 
2. Anticipated need for hospitalization or emergency room care within 24 hours of 
Screening. 
3. Receipt of systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy 
within 7 days of Screening and for the duration of the study. 
4. Awareness of concomitant respiratory infections that are viral (other than RSV), 
bacterial, or fungal, including systemic bacterial or fungal infections, within 7 days of 
Screening. 
5. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive within 28 days 
of Screening or at Screening following signature of full ICF. 
6. Frailty scale score ≥4 at Screening. 
7. History of chronic liver disease (eg, hemochromatosis, Wilson’s disease, alpha-1 
antitrypsin deficiency, autoimmune hepatitis, nonalcoholic steatohepatitis, and/or 
alcoholic liver disease); a history of biliary disease (eg, primary sclerosing cholangitis, 
cholecystitis, choledocholithiasis); or a history of portal hypertension. A diagnosis of 
hepatic steatosis (fatty liver) is not exclusionary.  
8. Heart disease: any congenital heart disease, acute or chronic heart failure, ischemic heart 
disease, congenital long QT syndrome, or any clinical manifestation resulting in QT 
interval prolongation. Note: Subjects with controlled hypertension without cardiac 
compromise will be allowed to enroll. See exclusion criterion #18 for prohibited 
medications. 
9. Neurological and neurodevelopmental disorders (including disorders of the brain, spinal 
cord, peripheral nerve, and muscle, eg, cerebral palsy, epilepsy [seizure disorders], 
stroke, muscular dystrophy, or spinal cord injury). Note: Minor neurological disorders 
(eg, past concussions, headaches, migraine) are allowed. 
10. Malignant tumor or history of malignancy that may interfere with the aims of the study or 
a subject completing the study. 
11. Prior receipt or the subject is waiting to receive a bone marrow, stem cell, or solid organ 
transplantation.  
12. Diagnosis of cystic fibrosis.  
13. Known positive human immunodeficiency virus, active hepatitis A virus infection, 
chronic hepatitis B virus infection, and/or current or treated hepatitis C virus infection.  


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14. Prior or planned ileal resection or bariatric surgery. Note: Subjects who have undergone 
gastric surgeries that do not affect drug absorption (eg, gastric band or gastric sleeve 
procedures) will be allowed to participate if they are stable for at least 1 year prior to 
Screening. Gastrectomy will be allowed if stable for at least 3 years prior to Screening.  
15. Pregnant or nursing female subjects. 
16. History of alcohol addiction or current heavy alcohol use defined as: >14 standard drinks 
per week and/or ≥4 standard drinks per occasion for males and >7 standard drinks per 
week and/or ≥3 standard drinks per occasion for females. A standard drink is 12 oz of 
beer (5% alcohol), 5 oz table wine (12% alcohol), or 1.5 oz of spirits (40% alcohol).  
17. Known or suspected, in the opinion of the Investigator, renal disease or renal impairment.  
18. Twelve-lead ECG demonstrating a QT interval corrected for heart rate according to 
Fridericia (QTcF) that is >500 msec or other clinically relevant abnormalities as judged 
by the Investigator at Screening. 
19. Use of or intention to use excluded or contraindicated medication(s) or supplements, 
including any medication known to be a moderate or potent inducer or inhibitor of 
CYP3A4 enzyme, within 14 days prior to Screening and for the duration of the study. 
20. Receipt of ≥14 days of systemic immunomodulator therapy (eg, oral corticosteroids) 
within 3 months of Screening. 
21. Prior to the first dose of study drug and during study participation, the subject has 
received any vaccine, investigational agent, or biological product within 30 days or 
5 times the half-life, whichever is longer. Note: Influenza vaccination within 7 days of 
Screening is not allowed. 
22. Use of St John’s wort within 28 days prior to the first dose of study drug and for the 
duration of the study. 
23. History of or currently experiencing a medical condition or any other finding (including 
laboratory test results) that, in the opinion of the Investigator, might confound the results 
of the study; pose an additional risk in administering study drug to the subject; could 
prevent, limit, or confound the protocol-specified assessments; or deems the subject 
unsuitable for the study.  
Additional Exclusion Criteria for Subjects With Asthma  
24. Subjects must not have experienced a severe asthma exacerbation (defined as worsening 
asthma that requires treatment with oral corticosteroids for 3 or more days, or emergency 
room attendance) or deterioration in asthma requiring an increase in asthma treatment for 
at least 6 weeks prior to Screening. 
25. Subject is receiving more than two maintenance asthma therapies or theophylline 
preparations for asthma treatment. 
26. Pulse oximetry reading of <90% oxygen saturation measured at rest at Screening. 


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Additional Exclusion Criteria for Subjects With COPD 
27. Receipt of theophylline, roflumilast, maintenance oral corticosteroids, or long-term 
oxygen therapy (defined as prescribed for 12 or more hours per day).  
28. Exacerbation of COPD requiring treatment with systemic corticosteroids and/or 
antibiotics, or emergency room attendance or hospitalization within 6 weeks prior to 
Screening.  
29. More than three COPD exacerbations with the past 12 months. 
30. Pulse oximetry reading of <90% oxygen saturation measured at rest at Screening. 


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4. 
STUDY DESIGN  
This is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study of EDP-938 
administered orally for the treatment of acute URTI with confirmed RSV infection in ambulatory 
adult subjects. 
The study is composed of 3 periods:  
• Screening Period will occur on Day 1. During this period, subjects will review and sign 
the Rapid Viral Screen ICF. Subjects will undergo a rapid diagnostic screen for RSV and 
influenza virus using respiratory secretions obtained by nasal (or nasopharyngeal) swab 
collection. Subjects whose swab sample tests positive for RSV and negative for influenza 
virus will review and sign the full study ICF and may proceed for further screening 
procedures. RSV positive and influenza negative subjects will be tested for SARS-CoV-2 
at Screening and subjects who have positive test results for SARS-CoV-2 will be 
excluded from the study. 
• Treatment Period will begin with the first dose of study drug on Day 1 and will conclude 
with the end-of-treatment (EOT) Visit on Day 5. 
• Follow-up Period for safety will begin following the last dose of study drug and will 
conclude at the end-of-study (EOS) Visit on Day 14, 9 days following the last dose of 
study drug.  
4.1 
Dose and Treatment Schedule 
Subjects who meet all inclusion criteria and none of the exclusion criteria will be eligible to enter 
the study and will be randomized 1:1 to receive 800 mg of EDP-938 or placebo once daily for a 
total of 5 days. An overview of the study design is shown in Figure 1. Study site visits and 
assessments are detailed in the Schedule of Assessments (SoA; Appendix 1).  
Figure 1: Study Design 
 
Abbreviations: d = day; FLU = influenza virus; RSV = respiratory syncytial virus. 


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4.2 
Rationale for Study Design  
This proposed study will evaluate EDP-938 in adult subjects with confirmed RSV, who will be 
randomized to receive either 800 mg of EDP-938 or placebo in a 1:1 ratio. 
4.2.1 
Justification of Study Design, Endpoints, and Subject Population 
Despite the significant medical need, there is no vaccine or highly effective treatment currently 
available for RSV. At present, there are only two agents approved for the prevention or treatment 
of RSV lower respiratory tract disease, a prophylactic agent (palivizumab) and a therapeutic 
agent (aerosolized ribavirin); each having indications for use that are limited to the pediatric 
population. Analyses performed subsequent to the approval of aerosolized ribavirin suggest that 
it failed to impart any clinically significant benefits (Randolph and Wang, 1996). Consequently, 
physicians have no safe and highly effective treatment for RSV infection. This is an issue of 
significant concern for those providing medical care for patients at risk of severe RSV disease, 
including the elderly, those with chronic lung and/or heart diseases, immunosuppressed 
individuals, and pediatric patients. In these populations, RSV infection may be associated with 
significant morbidity and even mortality. 
This Phase 2b study aims to evaluate the efficacy and safety of EDP-938 in an adult population 
with early detection of RSV infection as well as early initiation of EDP-938. In order to more 
fully investigate the efficacy of EDP-938, and noting the lack of a highly effective RSV therapy, 
a double-blind, placebo-controlled study design was selected, where subjects will be randomized 
to receive either 800 mg of EDP-938 or placebo in a 1:1 fashion. The study endpoints include 
efficacy and safety assessments. The primary endpoint is based on the subject’s twice daily 
assessment of defined, RSV-related, clinical symptoms over the course of the 14-day study. 
These data will enable the calculation of the AUC for the TSS as was used in the Phase 2a 
EDP 938-101 study. The antiviral efficacy will be assessed as the AUC for RSV RNA 
quantitation by nasopharyngeal swab over the course of the 14-day study. The RSV RNA AUC 
assessment was similarly employed in the Phase 2a EDP 938-101 study. Safety and PK 
assessments will also be summarized in relation to study treatment group. 
The eligible population comprises non-hospitalized individuals who have RSV infection and 
who may have permissible comorbidities. This includes subjects who are otherwise healthy, aged 
up to 75 years, have a BMI up to 40 kg/m2, and those with asthma or COPD that is stable and 
less severe by established guidelines. Individuals with asthma or COPD are at risk for more 
significant RSV disease. These individuals may be more sensitive to early onset of URTI 
symptoms and thus may be more likely to present for RSV screening. At this stage of 
development, subjects with more severe or unstable asthma or COPD are excluded from study 
participation. Similarly, the study also excludes subjects who are not considered to be medically 
stable or who require urgent, emergency medical care or hospitalization. Also excluded are 
subjects with known liver, kidney, heart and/or neurologic disease, and those who are frail. 
Because the window for optimal intervention for RSV infection may be discrete, the screening 
process is optimized to allow rapid identification of subjects with RSV (but who do not have 
influenza virus) and who are otherwise appropriate for the study so that EDP-938 (or placebo) 






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 These systemic EDP-938 exposures are expected to be generally 
safe and efficacious. 








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the site staff will ask the subjects why any doses were missed, if applicable. Any potential 
reasons for lack of compliance with dosing will be monitored and followed up by the site staff. 
Compliance assessment may be completed at the study site or by a study nurse via a home visit, 
if feasible; refer to the SPM for details. 
The time and date of doses of study drug taken at the study site should be recorded by site staff. 
From Day 1, subjects will electronically record the time and date that each dose is taken. In case 
the subject is unable to complete any assessments or recordings into the device for technical 
reasons, the subject will also be provided with a paper diary(ies) as a back-up. 
For any subject considered to demonstrate continued noncompliance of study drug dosing 
despite continued educational efforts, the Investigator should contact the 
 or the Sponsor’s 
Medical Monitor to discuss possible discontinuation of the subject from the study. 
5.8 
Concomitant Medications 
All subjects enrolled in the study must abstain from taking any prohibited medications through 
the end of the study (see Section 5.9).  
If RSV symptoms occur, such as fever or headache that require symptomatic relief during the 
study, then subjects may take acetaminophen at a dose of 3000 mg/day or less. Acetaminophen 
will be permitted only for the relief of fever or pain. From Day 1, subjects will electronically 
record the date and time of any acetaminophen use. In case the subject is unable to complete any 
recordings into the device for technical reasons, the back-up paper diary may be completed by 
subjects
 
 
 
For subjects with physician-diagnosed asthma, current GINA Steps 2, 3, or 4 treatment will be 
allowed as long as the dose is stable for at least 4 weeks prior to Screening. The GINA treatment 
guidelines (ie, main report and pocket guide) may be accessed at: https://ginasthma.org/reports/. 
Administration of more than two maintenance asthma therapies or theophylline preparations will 
not be allowed for study participation.  
For subjects with physician-diagnosed COPD, short-acting bronchodilators (as required) are 
permitted. No more than two maintenance therapies are permitted. Receipt of theophylline, 
roflumilast, maintenance oral corticosteroids, or long-term oxygen therapy (defined as prescribed 
for 12 or more hours per day) will not be allowed for study participation. 
Details of prior and concomitant medication use will be recorded in the source documentation 
and the electronic case report form (eCRF) as indicated in the SoA (Appendix 1). 
5.9 
Prohibited Medications 
Receipt of systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy within 
7 days of Screening and for the duration of the study are prohibited. The use of the following 




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6. 
BLINDING  
The study will be double-blinded, meaning that the subjects, investigators, and site staff will be 
blinded to treatment assignment until the completion of the study. All site staff will be blinded to 
treatment assignment except for the following individuals:  
• Unblinded Enanta
 statistician for purpose of generating and monitoring the 
randomization list 
• Unblinded Enanta representatives not associated with the day-to-day conduct of the study 
as outlined in a separate DSMB charter 
• Unblinded members of the DSMB for purposes of unblinded data review 
• Unblinded Drug Supply Chain personnel for the purpose of monitoring drug supplies 
• Enanta
Pharmacovigilance Group and Regulatory Affairs representatives when 
required to satisfy regulatory reporting requirements 
• Bioanalytical laboratory for the purpose of measuring drug concentrations 
6.1 Unblinding  
At the initiation of the study, the study site will be instructed on the method for breaking the 
blind. The unblinding method will use the IWRS process. 
Unblinding of individual subject treatment by the Investigator should be limited to medical 
emergencies or urgent clinical situations in which knowledge of the subject’s study treatment is 
necessary for clinical management. In such cases, the Investigator must first attempt to contact 
the 
 Medical Monitor to discuss and agree to the need for unblinding. In situations which the 
Investigator has attempted and failed to contact the 
 Medical Monitor and/or the urgency of 
the case requires immediate action, investigators should use their best judgment, based on the 
nature and urgency of the clinical situation, and proceed with unblinding. 
For unblinding, in the event that the local 
Medical Monitor cannot be reached, sites at all 
locations should call the following 24/7 global medical coverage hotline: 
 
Once a subject’s treatment assignment has been unblinded for a medical emergency or urgent 
clinical situation, the 
 Medical Monitor and study coordinator should be notified within 
24 hours of unblinding of the treatment. Information relating to unblinding (eg, the reason, date) 
should be clearly recorded in the subject’s study file. In addition, the Investigator should 
consider whether the clinical event that prompted unblinding should be considered an SAE, 
according to the regulatory definitions or criteria for SAEs, and if so, submit an SAE report as 
described in Section 9.2. 
The 
 group will also unblind any SAE reports in compliance 
with regulatory reporting requirements. In addition, Enanta Pharmaceuticals, Inc. may unblind 
individual subjects at any time for matters relating to safety concerns.  
Note: Investigative sites will be provided country-specific toll-free telephone and fax numbers.  


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7. 
STUDY CONDUCT AND VISIT SCHEDULE  
7.1 
Study Site Visits 
Details of assessments at each study site visit are presented in the SoA (Appendix 1). Also refer 
to the SPM. Study sites will be responsible for following up with subjects for any missed study 
site visits. 
7.1.1 
Screening Period on Day 1 
Screening procedures will occur after the subject signs and dates an institutional review board 
(IRB)- or ethics committee (EC)-approved ICFs and provides authorization to use protected 
health information (see Section 12.1.3). The ICFs will be completed prior to conduct of any 
study-specific assessments.  
At Screening (on Day 1), subjects will first review and sign the Rapid Viral Screen ICF prior to 
RSV and influenza screening. Subjects will undergo a rapid diagnostic screen for RSV and 
influenza virus using respiratory secretions obtained by nasal (or nasopharyngeal) swab 
collection; refer to the Laboratory Manual for details. Subjects whose swab sample test results 
positive for RSV and negative for influenza virus may proceed for further screening. Such 
subjects will be required to sign the full study ICF prior to performing any further study-specific 
assessments. After signing the full study ICF, subjects will undergo further screening procedures 
to determine study eligibility. 
All study screening activities should be completed on Day 1. If any assessment is anticipated to 
fall outside of that window, then the Investigator should consult with the 
 Medical Monitor 
to determine if the subject can proceed. For subjects who sign the full study ICF and whose swab 
sample test results are positive for RSV and negative for influenza virus, the first screening 
activity should be to test subjects for severe acute respiratory syndrome coronavirus 2 
(SARS-CoV-2) using a rapid molecular diagnostic test. Subjects will not be randomized until all 
screening activities that allow assessment of inclusion/exclusion criteria have been completed to 
the satisfaction of the Investigator, including the screening ECG and the screening urine 
pregnancy test. 
All screening procedures are detailed in the SoA (Appendix 1).  
7.1.2 
Treatment Period (Days 1 to 5) 
Study Site Visits (Days 1, 3, and 5):  
Subjects who meet all inclusion criteria and none of the exclusion criteria to the satisfaction of 
the Investigator will be eligible to enter the study and will be randomized 1:1 to receive 800 mg 
of EDP-938 or placebo. Subject randomization will be stratified by the presence or absence of 
asthma/COPD.  
Eligible subjects must complete the Day 1 biological sample collections (ie, blood, urine, and 
nasopharyngeal swab[s]) prior to receiving the first dose of EDP-938 or placebo. Day 1 blood 


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and urine samples will be sent to both local (expedited testing and reporting) and central 
laboratories. Nasopharyngeal swab(s) will be sent to the central laboratory only. 
Eligible subjects will receive an electronic data capture handheld device (ERT® electronic 
clinical outcome assessment [eCOA] Handheld eDiary) to use for the duration of the study. 
 
 
The device will also serve to alert the subject when it is time for study drug dosing. The subject 
will receive instruction on the proper use and care of the device, including the recording of the 
first dose, and the device should be brought to each study site visit. In case the subject is unable 
to complete any assessments or recordings into the device for technical reasons, the subject will 
also be provided with a paper diary(ies) as a back-up. 
The subject will be instructed on the use of concomitant medications during the study, including 
the use of acetaminophen as the study-specific analgesic/antipyretic (see Section 5.8 and 
Section 5.9). 
Subjects will receive the first dose of study drug while at the study site. After the first dose, 
subjects will be instructed to take 800 mg of EDP-938 or placebo once daily at approximately the 
same time every day (±1 hour) on each of the 4 subsequent days. The subject will also receive 
instruction on the appropriate storage and transport of study drug (see Section 5.3).  
On Day 3 and Day 5 (EOT), subjects should bring their study drug with them as part of their 
study site visit 
 for drug accountability and for 
dosing of study drug on Day 5 as described in Section 5.7. If a subject is unable to attend the 
Day 3 and/or Day 5 study site visit, a home visit by a study nurse may be arranged, if feasible; 
refer to the SPM for details. It is anticipated that every reasonable effort will be made to ensure 
that subjects return to the site for the Day 3 and Day 5 visits. 
Subjects who discontinue treatment early (ie, prior to completing 5 days of dosing) should return 
to the study site within 24 hours and no more than 48 hours later to complete the EOS 
procedures.  
All study assessments during the Treatment Period are detailed in the SoA (Appendix 1). 
7.1.3 
Follow-up Period (Days 6 to 14)  
Study Site Visits (Days 9 and 14):  
Subjects should return to the study site for follow-up visits on Day 9 and Day 14 (EOS Visit) for 
post-treatment safety assessments. Visit assessments may be completed at the study site or by a 
study nurse via a home visit, if feasible; refer to the SPM for details. 
Subjects who discontinue the study early (ie, prior to Day 14) should return to the study site 
within 24 hours and no more than 48 hours later to complete the EOS procedures.  
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Throughout the study, safety for each subject in each study period will be evaluated by 
assessment of clinical laboratory findings, physical examination findings (as applicable), vital 
sign measurements, pulse oximetry measurements (only for subjects with asthma or COPD), and 
AEs. Any subject with ongoing AEs/SAEs at the EOS Visit should be followed up until 
resolution of their AE/SAE or until the Investigator has determined that the event has stabilized 
as discussed in Section 9.3. 
7.2 
Subject Withdrawal/Early Termination 
Subjects may withdraw from the study at any time at their own request, or subjects may be 
withdrawn at any time at the discretion of the Investigator or Enanta Pharmaceuticals, Inc. for 
safety, behavioral, or administrative reasons. However, the Investigator should consult with the 
 Medical Monitor where possible before prematurely removing a subject. For any subject 
who decides to withdraw from the study, the Investigator should inquire about the reason for 
withdrawal, request that the subject returns all unused investigational product(s), request that the 
subject returns for a final study site visit, if applicable, and follow up with the subject regarding 
any unresolved AEs. Although a subject may discontinue the study drug or the study early, every 
effort must be made for the subject to return to the site within 24 hours and no more than 
48 hours later to complete the EOS procedures.  
If a subject withdraws from the study and also withdraws consent for disclosure of future 
information, no further evaluations should be performed, and no additional data should be 
collected. Enanta Pharmaceuticals, Inc. may retain and continue to use any data collected before 
such withdrawal of consent. 
Any randomized subjects who withdraw or are withdrawn from the study will not be replaced. 
7.2.1 
Withdrawal Criteria 
Subjects may be discontinued from the study at any time if the subject, Investigator, or Sponsor 
determines that it is not in the best interest of the subject to continue participation. Reasons for 
discontinuation include the following: 
• AE 
• Lack of efficacy 
• Lost to follow-up 
• Withdrawal by subject 
• Protocol deviation (including noncompliance with study drug or study procedures) 
• Pregnancy 
• Study terminated by the Sponsor 
• Other 


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7.2.2 
Procedures for Early Discontinuation or Early Termination of Treatment 
Subjects who prematurely discontinue treatment early and have received at least one dose of 
study drug should return to the site within 24 hours and no more than 48 hours later and undergo 
the EOS procedures per the SoA (Appendix 1). Any subject who withdraws with ongoing 
AEs/SAEs should be followed up until resolution of their AE(s) or until the Investigator has 
determined that the AE(s) has stabilized. 
Site staff will attempt to contact any subject who does not return to the site for the EOS Visit at 
least three times using the subject’s preferred method of communication, followed by a letter 
requiring delivery notification if the three attempts were unsuccessful. Any subject who still 
cannot be reached following those attempts will be considered lost to follow-up. These subjects 
will be included in the PK and safety analysis as indicated in Section 11.3. 
7.2.3 
Documentation of Withdrawal of Subjects 
The reason for early withdrawal/termination/lost to follow-up of any subject from the study must 
be documented on the appropriate eCRF. If the reason for early withdrawal is an AE or an 
abnormal laboratory value, the specific event or test result, if available, should be recorded on 
the AE eCRF and the subject should be monitored until the event is resolved or deemed stable by 
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8. 
STUDY PROCEDURES/EVALUATIONS  
8.1 
Timing of Assessments 
The timing of assessments is shown in the SoA (Appendix 1). 
8.2 
Demographics and Medical History 
Demographics and baseline characteristics including date of birth or age, gender or sex, race, 
ethnicity, medical history, and smoking history will be obtained from each subject and entered in 
the eCRF as reported during Screening. Significant medical history will be obtained by 
consulting with the subject. As a general rule, all medical events occurring within the last 
6 months should be recorded. For events that occurred more than 6 months ago (and that are not 
ongoing), only significant or relevant events should be entered on the eCRF. Any items in the 
history that are still ongoing should be noted as such in the eCRF. All surgeries occurring in 
adulthood should be recorded in the eCRF, whereas surgical methods of contraception, if 
applicable, should only be documented in the source documents. 
If there is a question concerning a subject’s medical history, then medical records may be 
requested from the subject’s primary care physician, as appropriate.  
8.2.1 
Prior and Concomitant Medications 
Any medication taken during the course of the study through the end of the study will be 
recorded with indication, dosage, route of administration, and start and stop dates of 
administration. All subjects will be questioned about concomitant medication at each study site 
visit. 
8.3 
Clinical Evaluations 
8.3.1 
Vital Sign Measurements  
Vital signs include heart rate, respiratory rate, systolic and diastolic blood pressure, and body 
temperature. Vital signs will be measured at times shown in the SoA (Appendix 1) after the 
subject has been supine for a minimum of 5 minutes.  
8.3.2 
Electrocardiograms  
A resting 12-lead ECG will be performed locally and recorded at Screening on Day 1 as 
specified in the SoA (Appendix 1) after the subject has been supine for 5 minutes and before 
dosing. A standard bedside 12-lead ECG machine that calculates heart rate and measures PR, 
QRS, QT, RR, and QTcF intervals will be utilized.  


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At Screening on Day 1, the Investigator or designee should review the ECG for gross 
abnormalities and interval measurements of concern (absolute readings). The clinical 
interpretation by the Investigator or designee of the ECGs should be recorded on a hard copy of 
the ECG (ie, clinically significant or not clinically significant).  
An ECG may be repeated at the discretion of the Investigator to address suspected errors in 
performance. Prior to dosing, the screening ECG must be reviewed to confirm that no clinically 
significant cardiac abnormalities are present. 
8.3.3 
Physical Examination 
The Investigator or designee will perform the physical examination. A full physical examination 
will be conducted at Screening and will include examination of all pertinent body systems. Any 
subsequent physical examinations performed at the discretion of the Investigator will be targeted 
to new signs and symptoms including specific assessments of any changes from previous status. 
Only clinically significant abnormalities should be recorded in the eCRF (eg, use of contact 
lenses does not need to be recorded). 
8.3.4 
Height, Weight, and Body Mass Index 
Height and body weight should be obtained with the subject in light clothes and no shoes. Height 
will be documented at Screening only. Body mass index will be calculated at Screening (to 
assess eligibility) according to the following equation: 
BMI = weight (kg)/height (m)2 
These measurements will be obtained as specified in the SoA (Appendix 1). 
8.3.5 
Adverse Events 
The Investigator is responsible for the detection and documentation of events meeting the criteria 
and definition of an AE or SAE as provided in Section 9.1 of this protocol. All AEs and SAEs 
must be recorded in the source documents and eCRF as described in Section 9.2. At all study site 
visits, the Investigator or designee should inquire about the occurrence of AEs. The following are 
examples of open-ended questions that may be used to obtain this information: “How are you 
feeling?”; “Have you had any medical problems recently?”; and “Have you taken any new 
medicines since your last visit/assessment?” 
It is the Investigator’s responsibility to ensure any necessary additional therapeutic measures and 
follow-up procedures are performed and documented in the subject source notes and eCRF.  
8.3.6 
Pulse Oximetry 
At Screening, subjects diagnosed with asthma or COPD will have pulse oximetry performed to 
measure oxygen saturation and to ensure study exclusion criteria are not met (see Section 3.2). 


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Subsequent pulse oximetry measurements will be performed for subjects with asthma or COPD 
as indicated in the SoA (Appendix 1). 
8.3.7 
Frailty Scale Score 
At Screening, all subjects will have a frailty scale score documented by the Investigator or site 
staff based on subject interview and medical history to ensure that study exclusion criteria are 
not met (see Section 3.2). Frailty will be assessed by a validated 9-point scale (Rockwood et al., 
2005) or as otherwise indicated in the SPM. 
8.3.8 
Respiratory Syncytial Virus Symptom Diary 
At Screening and at timepoints indicated in the SoA (Appendix 1), subjects will assess the 
severity of RSV-related signs and symptoms and self-complete the 13-point RSV symptom 
diary. The 13-item diary will consist of grading symptoms on a scale of 0 to 3, where Grade 0 is 
absence, Grade 1 is just noticeable, Grade 2 is bothersome but does not prevent participation in 
activities, and Grade 3 is bothersome and interferes with activities. The 13 RSV symptoms 
assessed will comprise nasal discharge, nasal congestion, malaise/tiredness, headache, sinus 
congestion, sneezing, sore throat, hoarseness, cough, shortness of breath, respiratory wheeze, 
earache, and/or symptoms of fever. The RSV symptom diary will be completed twice daily at the 
same times each day ±2 hours as an eCOA. In case the subject is unable to complete the RSV 
symptom diary assessment for technical reasons, the subject will also be provided with a paper 
diary(ies) as a back-up. If a subject plans to take acetaminophen within 2 hours of the scheduled 
RSV symptom diary completion, then the RSV symptom diary should be completed immediately 
before the subject takes acetaminophen or 4 hours after taking acetaminophen. 
 
 
 
 
 
 
 
 
 
 
 
8.3.10 Collection of Nasal and Nasopharyngeal Swabs and Blood Samples 
Refer to Section 8.5 for samples that will be collected for virology assessments. The 
RSV-specific tests are indicated in Table 2. 


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8.4 
Laboratory and Diagnostic Procedures 
At Screening, the rapid viral diagnostic screen will be performed on site. Subsequent virology 
assessments will be sent to the central laboratory(ies). 
On Day 1, enrolled subjects will undergo the clinical laboratory evaluations of blood and urine 
samples specified Table 2, which will be performed at the local site laboratory (expedited testing 
and reporting) and the central laboratory(ies). Subsequent clinical laboratory evaluations will be 
performed by the central laboratory(ies). 
The Day 1 collection of blood, urine, and nasopharyngeal swab samples will be completed prior 
to administration of study drug.  
A Laboratory Manual will be provided to the site detailing kit contents, reordering supplies, 
sample collection, handling, storage, and shipment instructions. All unblinded laboratory values 
will be reviewed by the Investigator, documented, and the results maintained in the source 
documents. All out-of-range laboratory findings require an interpretation as to whether or not 
they are of clinical significance. Clinically significant laboratory findings in the opinion of the 
Investigator should be recorded as an AE (or SAE as appropriate) (see Section 9.1). 
8.4.1 
Routine Laboratory Panels 
Blood samples will be collected for analysis of the analytes as shown in Table 2. Samples will be 
collected from all subjects enrolled into the study.  
Blood and urine samples for clinical laboratory assessments will be collected according to the 
SoA (Appendix 1) and processed as indicated in the Laboratory Manual. Estimated creatinine 
clearance will be calculated using the Cockcroft-Gault equation using actual body weight.  
8.4.2 
Pregnancy and Menopausal Laboratory Testing 
All female subjects of childbearing potential will undergo a urine pregnancy test at Screening 
and at the EOS Visit. In addition, on Day 1, blood will be collected for a serum pregnancy test to 
be performed by the central laboratory. The screening urine pregnancy test results will be used to 
qualify subjects at study entry. 
To confirm nonsurgical postmenopausal status for women stating that they are amenorrhoeic for 
1 to 2 years, documentation of FSH levels >35 mIU/mL will be required. Where such 
documentation is not available, then FSH levels will be measured on Day 1. In such subjects, 
urine and serum pregnancy testing should also be performed at Screening, and these subjects will 
be required to follow appropriate contraceptive practices for women of childbearing potential 
until a confirming FSH level is available. 


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Table 2: 
Clinical and Respiratory Syncytial Virus Laboratory Evaluations 
CHEMISTRY PANEL 
Alanine aminotransferasea 
Albumin, seruma 
Alkaline phosphatase, seruma 
Amylasea 
Aspartate aminotransferasea 
Bilirubin, total and directa 
BUNa 
BUN/Creatinine ratio (calculation) 
Calcium, serum 
Creatine kinase  
Creatinine, seruma 
Creatinine clearance, estimated 
Uric acid 
Electrolyte panel (sodium, potassium, 
chloride, bicarbonate) a 
Phosphorus 
Gamma glutamyl transferase 
Globulin, total 
Glucose, seruma 
Cholesterol 
Triglycerides 
Lactate dehydrogenase 
Lipase 
Protein, total, serum 
HEMATOLOGY PANEL 
Hemoglobina 
Hematocrita 
Differential white blood cell count, percentage and absolute 
(basophils, eosinophils, lymphocytes, monocytes, neutrophils)a 
Mean corpuscular hemoglobin 
Mean corpuscular hemoglobin concentration 
Mean corpuscular volume 
Platelet counta 
Red blood cell count 
White blood cell counta 
International normalized ratioa 
Prothrombin timea 
Activated thromboplastin timea  
 
RSV-SPECIFIC AND OTHER VIROLOGY TESTS  
RSV and influenza A/B diagnostic test (nasal or nasopharyngeal 
secretions) 
SARS-CoV-2 diagnostic test (nasopharyngeal or oropharyngeal 
secretions) 
Confirmatory respiratory pathogen panel  
RSV RNA quantitation of viral load (nasopharyngeal secretions)  
 
RSV serology (neutralizing antibodies, serum, archived) 
URINALYSIS  
Routine urinalysis to include: Color and 
appearance, pH, specific gravity, bilirubin, 
glucose, ketones, leukocytes, nitrite, occult 
blood, protein, urobilinogen, microscopic 
examination (including red blood cells and 
white blood cells)a 
PREGNANCY AND OTHER TESTS  
Urine pregnancy test  
Serum pregnancy test (only Day 1 and to the central laboratory) 
Follicle-stimulating hormone 
Abbreviations: BUN = blood urea nitrogen; RSV = respiratory syncytial virus. 
a On Day 1, blood and urine samples should be taken from all eligible subjects and sent to the local laboratory for these identified 
tests, which should be assayed and reported in an expedited manner. In parallel, complete hematology, chemistry, and urine 
panels should be sent to the central laboratory with the other Day 1 samples. 
 


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8.5 
Virology Assessments 
Virology assessments and tests (see Table 2) will be performed using nasal (or nasopharyngeal) 
swab (rapid diagnostic screen) or nasopharyngeal swab samples (other virology assessments) and 
serology samples collected at Screening and at timepoints indicated in the SoA (Appendix 1) and 
as further described in the Laboratory Manual, including swab collection, sampling, and 
handling procedures. Note: Multiple nasopharyngeal swab samples may be collected at each 
timepoint; refer to the Laboratory Manual for details. With the exception of the rapid diagnostic 
test (for RSV and influenza A/B) that will be performed at the local site laboratory, all other 
virology/RSV assessments will be analyzed at the central laboratory(ies). 
8.5.1 
Respiratory Syncytial Virus, Influenza, and SARS-CoV-2 Rapid Molecular 
Diagnostic Tests 
After a subject reviews and signs the Rapid Viral Screen ICF, the subject will undergo a rapid 
molecular diagnostic screen for RSV and influenza A/B at the local site. Refer to the Laboratory 
Manual for details. A nasal (or nasopharyngeal) swab sample will be collected to obtain 
respiratory secretions. Subjects whose swab sample tests positive for RSV and negative for 
influenza virus and who agree to proceed, will be required to read and sign the full study ICF and 
may proceed for further screening assessments. Results will be recorded in the source 
documents. 
In the event that the rapid molecular diagnostic test is unavailable for technical reasons, then 
rapid antigen tests for RSV and influenza virus may be used as a back-up. The use of such tests 
and the results must be recorded in the source documents. 
Subjects, who sign the full study ICF and whose swab sample test results are positive for RSV 
and negative for influenza, will be screened for SARS-CoV-2 using a rapid molecular diagnostic 
test. 
8.5.2 
Confirmatory Respiratory Pathogen Panel  
Following randomization on Day 1, as specified in the SoA (Appendix 1), eligible subjects will 
have additional nasopharyngeal swab sample(s) taken prior to taking the first dose of EDP-938 
or placebo for central laboratory analysis and confirmation of respiratory pathogens recovered. 
This testing will be performed to identify other nasopharyngeal co-pathogens that may include 
adenovirus, coronavirus, human metapneumovirus, human rhinovirus/enterovirus, parainfluenza 
virus, Bordetella pertussis, Chlamydophila pneumoniae, and/or Mycoplasma pneumoniae, which 
may impact the course of a subject’s illness. Refer to the Laboratory Manual for further details. 


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8.5.3 
Respiratory Syncytial Virus RNA Quantification of Viral Load 
The RSV RNA viral load will be measured in nasopharyngeal swabs by RT-qPCR assay at the 
timepoints specified in the SoA (Appendix 1). The RT-qPCR will also be used to determine viral 
dynamics (eg, peak viral load and time to peak). Refer to the Laboratory Manual for further 
details. 
8.5.4 
Respiratory Syncytial Virus Subgroup (A or B) Determination 
Nasopharyngeal swab sample(s) will be analyzed to determine whether the virus belongs to RSV 
subgroup A or B. Refer to the Laboratory Manual for further details. 
8.5.5 
Viral Resistance 
Nasopharyngeal swab sample(s) may be analyzed for potential viral resistance monitoring 
assessment. Resistance monitoring assessment, if performed, will be conducted by population 
and/or deep sequencing of the RSV gene to monitor for treatment-emergent resistance mutations. 
Refer to the Laboratory Manual for further details. 
8.5.6 
Respiratory Syncytial Virus Serology 
At the timepoints specified in the SoA (Appendix 1), samples will be collected for RSV serology 
assessment using the RSV neutralization antibody assay. Refer to the Laboratory Manual for 
further details. 
8.6 
Pharmacokinetic Samples 
Blood (plasma) samples for PK analysis will be collected on Day 1 (postdose; at least 1 hour 
after dosing or right before the subject leaves the site, whichever is later), Day 3 (at the same 
approximate time as that of the nasopharyngeal swab collection), and Day 5 (predose). 
If the Day 5 study site visit occurs up to 4 hours after the time scheduled for dosing of study 
drug, then the subject should take the study drug at the site during the visit (refer to the SoA 
[Appendix 1]). If the Day 5 study site visit occurs more than 4 hours after the time scheduled for 
dosing of study drug, then subject should take the study drug at the scheduled time. On Day 5 if 
the subject takes the study drug prior to the study site visit (see Section 5.7), a PK sample should 
be taken at the same approximate time as that of the nasopharyngeal swab collection. 
At the EOS Visit, a PK sample is only required for subjects who discontinue the study before the 
last dose of study drug is taken. The PK sample should be collected at the same approximate 
time as that of the nasopharyngeal swab collection.  
Blood samples will be collected and processed to measure plasma concentrations of EDP-938 
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9. 
SAFETY MONITORING AND REPORTING 
9.1 
Definitions 
9.1.1 
Pretreatment Events 
A pretreatment event is any event that meets the criteria for an AE/SAE and occurs after the 
subject signs the ICF but before receiving the first administration of study drug. 
9.1.2 
Adverse Events 
An AE is any event, side effect, or untoward medical occurrence in a subject enrolled in a 
clinical study whether or not it is considered to have a causal relationship to the study drug. An 
AE can therefore be any unfavorable and unintended sign, symptom, laboratory finding outside 
of normal range with associated clinical symptoms or suspected latent clinical symptoms in the 
opinion of the Investigator, including those requiring therapeutic intervention, physical 
examination finding, or disease temporally associated with the use of the study drug, whether or 
not the event is considered related to the study drug.  
The occurrence of AEs should be sought by nondirective questioning of the subject at each study 
site visit during the study. Adverse events also may be detected when they are volunteered by the 
subject during or between study site visits or through physical examination, laboratory test, or 
other assessments. 
Planned hospital admissions or surgical procedures for an illness or disease that existed before 
the subject was enrolled in the study are not to be considered AEs unless the condition 
deteriorated in an unexpected manner during the study (eg, surgery was performed earlier than 
planned). 
9.1.3 
Serious Adverse Events 
An SAE is any untoward medical occurrence at any dose that:  
• Results in death: This includes deaths that appear to be completely unrelated to study 
drug (eg, a car accident)  
• Is a life-threatening event: An event that places the subject at immediate risk of death at 
the time of the event; it does not refer to an event that hypothetically might have caused 
death if it were more severe  
• Requires inpatient hospitalization or prolonged hospitalization of an existing 
hospitalization, unless hospitalization is for: 
o Routine treatment or monitoring of the studied indication, not associated with any 
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o Elective or preplanned treatment for a pre-existing condition that is unrelated to the 
indication under study and has not worsened since signing the ICF 
o Treatment on an emergency outpatient basis for an event not fulfilling any of the 
definitions of a SAE given above and not resulting in hospital admission 
o Social reasons and respite care in the absence of any deterioration in the subject’s 
general condition 
• Results in permanent or prolonged (at least 28 days in duration) disability or incapacity  
• Is a congenital anomaly or birth defect in the offspring of a study subject  
• Medically important event: An event that may not be immediately life-threatening, or 
result in death or hospitalization, or require intervention to prevent one of the outcomes 
listed above but is considered medically significant for other reasons. An opportunistic or 
otherwise unusual infection for the Investigator’s practice, such as tuberculosis, will be 
considered medically significant.  
The term severe is used to describe the intensity of a specific event (as in mild, moderate, or 
severe); the event itself, however, may be of minor medical significance (such as severe 
headache). This is not the same as serious, which is based on outcome of the event, as described 
above. Seriousness, not intensity, serves as a guide for defining regulatory reporting obligations. 
9.2 
Documenting and Reporting of Adverse Events (Including Serious Adverse Events) 
Adverse events will be evaluated and documented using the grading scales contained in the 
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 
Version 4.03. 
9.2.1 
Documenting and Reporting Adverse Events 
All AEs reported from the time of informed consent to the EOS Visit for each subject will be 
recorded in the subject’s source documents. For subjects who do not receive study drug (ie, 
alternates or screen failures), AEs will only be recorded in the source documents. For subjects 
enrolled into the study (ie, randomized), all AEs will be recorded in the subject’s AE eCRF and 
the SAE Form (if applicable). The AE eCRF will indicate if the event occurred prior to the first 
dose of study drug, during treatment, or during the postdose Follow-up Period. The site should 
record all AEs regardless of the intensity, seriousness, or relationship to study drug. 
Adverse events (serious and nonserious) will be graded in accordance with the NCI-CTCAE 
scale as follows:  
• Mild (Grade 1): asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated 
• Moderate (Grade 2): minimal, local or noninvasive intervention indicated; limiting 
age-appropriate instrumental activities of daily living 


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• Severe (Grade 3): severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care 
activities of daily living 
• Life-threatening (Grade 4): life-threatening consequences; urgent intervention indicated  
• Death (Grade 5): death related to the AE 
Any recurrence of an AE with similar causality to study drug will be reported as recurrence or 
exacerbation of the initial event, and not as a new event. Whenever possible, AEs will be 
reported as a specific diagnosis or syndrome (eg, flu syndrome) rather than as individual signs or 
symptoms. If no specific diagnosis or syndrome is identified, AEs should be reported as separate 
and individual events.  
An AE includes the following:  
• Progression or exacerbation of the subject’s underlying disease. Clinical sequelae that 
result from disease progression, such as pleural effusion or small bowel obstruction, are 
reportable as AEs  
• Pre-existing event that increases in frequency or intensity  
• Condition detected or diagnosed during the study period, even though it may have been 
present, in retrospect, prior to the first dose of study drug 
• Laboratory abnormalities outside of normal limits with associated clinical symptoms or 
suspected latent clinical symptoms in the opinion of the Investigator, including those 
requiring therapeutic intervention 
• An overdose of the study drug without any signs or symptoms will be considered an AE. 
A calculated dose that exceeds its correct dose by 10% or more and is administered to the 
subject will be considered an overdose and documented as an AE  
The following events will not be identified as AEs in this study:  
• Medical or surgical procedures (eg, surgery, endoscopy, tooth extraction, etc); however, 
the condition (the “triggering event”) that leads to the procedure may be an AE  
• Pre-existing conditions present or detected prior to the first dose of study drug that do not 
worsen 
9.2.2 
Assigning Attribution of Adverse Events 
The Investigator must attempt to determine the cause of each event. Every effort will be made by 
the Investigator to assess the relationship of each AE to study drug. To ensure consistency of 
AE/SAE causality assessments, the Investigator should apply the following guidelines:  
• Related: There is an association between the event and the administration of study drug, 
a plausible mechanism for the event to be related to the study drug and causes other than 


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the study drug have been ruled out, and/or the event reappeared on re-exposure to the 
study drug.  
• Possibly related: There is an association between the event and the administration of the 
study drug and there is a plausible mechanism for the event to be related to study drug, 
but there may also be alternative etiology, such as characteristics of the subject’s clinical 
status or underlying disease.  
• Unlikely related: The event is unlikely to be related to the study drug and likely to be 
related to factors other than study drug.  
• Not related: The event is related to an etiology other than the study drug (the alternative 
etiology must be documented in the study subject’s medical record). 
9.2.3 
Classifying Action Taken With Study Drug 
In the case of an AE, the actions that can be taken with study drug are defined in Table 3. 
Table 3: 
Options for Action Taken With Study Drug 
Classification  
Definition  
Dose Not Changed  
Study drug dose not changed in response to the adverse event  
Drug Interrupted  
Study drug administration interrupted in response to an adverse event  
Drug Withdrawn  
Study drug administration permanently discontinued in response to an adverse 
event  
Not Applicable  
Action taken regarding study drug administration does not apply. “Not applicable” 
should be used in circumstances when no opportunity to decide whether to 
continue, interrupt, or withdraw treatment was possible such as when the 
investigational treatment had been completed before the adverse event began.  
9.2.4 
Classifying Adverse Event Outcome 
For every AE/SAE, the possible outcomes of the event and the definition of the outcome are 
shown in Table 4. One outcome must be entered into the appropriate field on the AE and (if 
appropriate) SAE Form for each event as discussed in the eCRF instructions. 






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10. 
SUBJECT SAFETY MANAGEMENT/ STUDY STOPPING 
RULES  
10.1 Study Stopping Rules 
If any of these events occur, dosing will be placed on hold pending a full review of all available 
clinical safety data and discussion with the investigators and the DSMB. 
• Two or more subjects receiving EDP-938 experience a similar Grade 3 study drug-related 
AE, including a confirmed treatment-emergent Grade 3 laboratory abnormality  
• One or more subjects receiving EDP-938 experience a study drug-related SAE 
• One or more subjects receiving EDP-938 experience Grade 4 or higher AE or a 
confirmed treatment-emergent laboratory abnormality regardless of causality attribution 
to study drug 
10.2 Site or Study Discontinuation 
10.2.1 Study Discontinuation 
The Sponsor has the right to terminate this study at any time. Reasons for terminating the study 
may include, but are not limited to, the following: 
• The incidence or severity of AEs in this study indicates a potential health hazard to 
subjects 
• Subject enrollment is unsatisfactory 
• Data recording is inaccurate or incomplete 
• Investigator does not adhere to the protocol or applicable regulatory guidelines in 
conducting the study 
• A decision from the IRB/EC or regulatory authority to terminate the study 
If the study is suspended or terminated for safety reasons, Enanta Pharmaceuticals, Inc. will 
promptly notify the investigators and will also inform the regulatory authorities of the suspension 
or termination of the study and the reasons for the action. The Investigator is responsible for 
promptly informing the IRB/EC and providing the reasons for the suspension or termination of 
the study. 
10.2.2 Site Termination 
A single site may warrant termination under the following conditions: 
• Failure of the site to enroll subjects into the study at an acceptable rate 


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• Failure of the site to comply with pertinent governmental regulations as appropriate 
• Submission of knowingly false information from the research facility to the Sponsor, 
Clinical Monitor, or governmental authority 
• Failure to adhere to the protocol requirements 
• Data recording is inaccurate or incomplete 
• Investigator does not adhere to the protocol or applicable regulatory guidelines in 
conducting the study 
10.2.3 Study Termination Procedures 
If the study is terminated by Enanta Pharmaceuticals, Inc. for one of the reasons listed 
previously, or upon completion of the study, the following activities must be conducted by the 
Study Monitor and/or site staff: 
• Return of all study data to Enanta Pharmaceuticals, Inc. or designee 
• Respond to and complete all requests for data clarifications 
• Accountability and final disposition of used and unused study drug 
• Review of site records for completeness 
• Shipment of all applicable biological samples (including PK samples) to the designated 
laboratory 
 


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11. 
STATISTICAL CONSIDERATIONS 
11.1 General Considerations 
Statistical analysis of this study will be the responsibility of Enanta Pharmaceuticals, Inc. or its 
designee. Details of the statistical analysis methods will be described in the statistical analysis 
plan (SAP) document.  
Continuous endpoints will be summarized using n, mean, standard deviation, median, 
25th quartile, 75th quartile, minimum, and maximum values. Categorical endpoints will be 
summarized by the number of subjects meeting the endpoint and the percentage of subjects out 
of the appropriate population. The denominator will be displayed when needed. Statistical 
inference will be performed as appropriate. Inferential testing will be conducted using a 
two-sided alpha of 0.05, unless stated otherwise.  
Any change to the data analysis methods described in the protocol will require an amendment if 
it changes a principal feature of the protocol. Any other change to the data analysis methods 
described in the protocol, and the justification for making the change, will be described in the 
clinical study report or SAP. Changes may only be made in the SAP prior to unblinding. 
11.2 Sample Size Considerations 
Using a ratio of 1:1, a sample size of 27 subjects per treatment group (54 subjects total) provides 
80% power to detect a treatment reduction in TSS AUC of at least 55% from placebo (assuming 
TSS AUC from the previous Phase 2a clinical challenge study to: mean [standard deviation]) of 
placebo: 500 [450] and EDP-938: 225 [200]) using a t-test with unequal variance. Assuming a 
20% dropout rate, approximately 35 subjects per treatment group (approximately 70 subjects 
total) are needed. 
11.3 Analysis Populations 
The following analysis populations are planned:  
• Safety (SAF) Population: All subjects who receive at least one dose of study drug. 
Subjects will be analyzed in the treatment group that corresponds to the study drug 
received during the study. 
• Modified Intent-to-Treat (mITT) Population: All subjects who receive at least one dose of 
study drug. Subjects will be analyzed as treated. The mITT Population is designated as 
the primary efficacy population. 
• Per Protocol (PP) Population: All subjects who are randomized and receive all planned 
doses of study drug and do not have major protocol deviations that may unduly influence 
outcome. Subjects will be analyzed in the treatment group that corresponds to the study 
drug received during the study. 


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• Pharmacokinetic (PK) Population: All subjects receiving active study drug and having 
any measurable plasma concentration of study drug at any timepoint. 
11.4 Subject Disposition and Demographic Data 
The number of subjects screened, randomized, and in the SAF, mITT, and PK Populations will 
be summarized using frequencies and percentages. The denominator for the calculation of 
percentages will be from the number of subjects randomized.  
The following categories will also be summarized for subject disposition:  
• Completed study drug per the protocol  
• Discontinued study drug early and the reason for discontinuation  
• Completed the study  
• Discontinued from the study early and the reason for discontinuation  
Subject demographics will be summarized by treatment group for all subjects in the SAF 
Population. Appropriate baseline characteristics will be included in addition to demographic 
characteristics. No statistical testing will be performed. 
11.5 Method of Treatment Assignment 
Subjects who meet all criteria for enrollment will be randomized to blinded treatment on Day 1 
in a 1:1 ratio to 800 mg of EDP-938 or placebo. Assignment to treatment groups will be 
determined by a computer-generated random sequence using an IWRS. The IWRS will be used 
to assign investigational product to each subject. To achieve between-group comparability, the 
randomization will be stratified by asthma/COPD status. 
11.6 Efficacy Analyses  
11.6.1 Primary Efficacy Analyses 
The primary efficacy analysis will be performed on the TSS AUC. The TSS AUC is measured 
twice daily (before or after treatment, morning/evening) using the 13-point symptom scale. Date 
and time of completion and symptom severity (graded 0 to 3) will be recorded. The TSS will be 
derived for each from the last nonmissing measurement (Baseline) collected prior to dosing to 
the final on Day 14. The average daily TSS will be computed as part of the primary efficacy 
endpoint. The AUC will be calculated using the trapezoid rule (Matthews et al., 1990). The TSS 
will be compared between EDP-938 and placebo using an analysis of covariance (ANCOVA) 
model with treatment group and stratification factor as fixed effects and the baseline TSS as a 
covariate. Treatment groups will be compared using a type III sum-of-squares. The least-squares 
means and two-sided 95% confidence intervals (CI) will be presented for individual groups and 


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the difference between groups. Descriptive statistics will include at a minimum the number of 
nonmissing measurements, mean, median, minimum, maximum, and 95% CI for the mean. 
11.6.2 Secondary Efficacy Analyses 
Sensitivity analysis of the primary endpoint will be performed using the Markov Chain Monte 
Carlo (MCMC) method of multiple imputation (Dong and Peng, 2013). Following imputation 
using MCMC methods, the TSS AUC will be calculated and an ANCOVA model with treatment 
group and stratification factor as fixed effects, and the baseline TSS as a covariate will be 
performed. Treatment groups will be compared using a type III sum-of-squares. Other sensitivity 
analysis may include a mixed model repeated measures analysis on the change from Baseline 
over all visits. 
The RSV RNA viral load AUC measured in nasopharyngeal swab samples by RT-qPCR will be 
measured on Days 1, 3, 5, 9, and 14. The trapezoid rule will be used to calculate the AUC of the 
RSV RNA viral load. An ANCOVA model with treatment group and stratification factor as fixed 
effects and the baseline RSV RNA viral load as a covariate will be performed. Treatment groups 
will be compared using a type III sum-of-squares. The proportion of subjects with RSV RNA 
below the lower limit of quantitation will be analyzed on Days 3, 5, 9, and 14. Treatment groups 
will be compared using a Cochran-Mantel-Haenszel test controlling for the stratification factor. 
11.7 Safety Analyses 
Statistical methods for the safety analyses will be primarily descriptive in nature. Safety data, 
including AEs, vital sign measurements, pulse oximetry (only for subjects with asthma or 
COPD), concomitant medications, and laboratory values, will be summarized separately by 
treatment group. Change from Baseline will be included in summary tables for vital sign 
measurements and laboratory parameters. Shift tables will also be generated by laboratory 
analyte. All laboratory data will be included in the data listings, and all test values outside the 
normal range will be flagged. 
11.7.1 Treatment Compliance 
Listing of the randomization schedule and study drug dispensed with lot number will be 
provided. Treatment compliance for each subject will be calculated as the number of subjects 
receiving the amount of drug taken divided by the amount prescribed multiplied by 100. 
11.7.2 Adverse Events 
Adverse events will be summarized by the Medical Dictionary for Regulatory Activities system 
organ class and preferred term by treatment group. All subjects in the SAF Population will be 
included in the summaries. Treatment-emergent AEs (TEAEs) are defined as reported AEs that 
first occurred or worsened during the post-Baseline phase compared to Baseline. The maximum 
severity at Baseline will be used as baseline severity. If the maximum severity during 


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post-Baseline is greater than the maximum baseline severity, then the event is considered 
treatment emergent. No statistical testing will be performed.  
Summaries of AEs will include the following at a minimum:  
• An overall summary of AEs with a line for each of the categories provided below:  
o TEAEs  
o Related TEAEs  
o Maximum severity TEAE  
o TEAEs by severity  
o TEAEs leading to study drug discontinuation  
o AEs leading to death  
o SAEs  
o Related treatment-emergent SAEs  
11.7.3 Clinical Laboratory Data 
Laboratory assessments will be reported as mean change from Baseline across scheduled visits, 
and as the incidence rate of shift change from Baseline. Shift from Baseline tables will be 
generated for each treatment group for selected analytes. Laboratory shifts will be displayed as 
treatment-emergent abnormal, high, or low results. The following details the summary types 
where LLN = lower limit of normal and ULN = upper limit of normal.  
For categorical tests: Treatment-emergent abnormal is defined as a change from normal at 
Baseline to abnormal at any post-Baseline visit.  
For continuous tests: 
• Treatment-emergent high is defined as a change from a result less than or equal to the 
high limit at Baseline to a value greater than the high limit at any time post-Baseline. 
Results will be reported according to any value greater than the high limit, any value 
greater than 2× ULN and 3× ULN.  
• Treatment-emergent low is defined as a change from a result greater than or equal to the 
low limit at Baseline to a value less than the low limit at any time post-Baseline.  
Results will be reported to any value less than the lower limit, any value less than 
2× LLN and 3× LLN. 
11.7.4 Vital Sign Measurements 
The incidence rate of subjects with treatment-emergent vital sign changes at any post-Baseline 
visit will be summarized. Specific criteria for the classification of treatment emergent will be 


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documented in the SAP. Vital sign observed, change, and percentage change will be summarized 
by treatment over visits. 
11.7.5 Electrocardiograms 
Screening ECG data will be provided in data listings. 
11.7.6 Pulse Oximetry 
Pulse oximetry measurements will be summarized by visit and treatment. 
11.7.7 Concomitant Medications 
The number and percentage of subjects taking concomitant medications will be coded according 
to the latest World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) 
Classification level 4 and WHO preferred term. Summaries will be provided by ATC Level 4 
and preferred term. Subjects in the SAF Population will be summarized by treatment group. 
11.7.8 Physical Examinations 
Physical examination data will be provided in data listings. 
11.8 Pharmacokinetic Analyses 
Summary of plasma concentration data will be descriptive in nature. Available plasma 
concentration-time data in the PK Population will be summarized by treatment group. Mean 
plasma concentration-time figures may be created for EDP-938 
, as allowed 
by the data. Additional details will be provided in the SAP. 
11.9 Subgroup and Covariate Analyses 
Subgroup analyses will be performed on the primary and secondary endpoints, primarily. A 
logistic regression model will be planned when categorical endpoints are analyzed. The model 
will include treatment group and stratification factor as fixed effects, with subgroup and 
subgroup-by-treatment interaction as well. Odds ratios and 95% CI will be reported. For 
continuous endpoints, an ANCOVA model with treatment group and stratification factor as fixed 
effects in the model, with subgroup and subgroup-by-treatment interaction as well. 
Various study populations may be used. Forest plots will be provided to visually describe the 
association. 


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11.11 Interim Analyses 
No interim analysis will be performed in this study. 


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12. 
STUDY ADMINISTRATION 
12.1 Ethical Considerations  
12.1.1 Ethical Conduct of the Study 
The study will be conducted in compliance with this protocol, principles of E6 Good Clinical 
Practice: Consolidated Guidance (ICH-GCP), Declaration of Helsinki, and all applicable local 
laws and regulations governing clinical studies. 
12.1.2 Ethical Review 
It is the Investigator’s responsibility to ensure that this protocol is reviewed and approved by an 
appropriate IRB/EC that conforms to the regulations set forth in FDA 21 Code of Federal 
Regulations (CFR) Part 56 and other national, country, and regional regulations as applicable. 
The Investigator must also submit the ICF, any other written documentation provided to the 
subject, and all advertisements that may be used for study-specific recruitment to the IRB/EC for 
review and approval before commencing study-specific assessments. If it is necessary to amend 
the protocol during the study, then it is the responsibility of the Investigator to ensure that 
IRB/EC approval is obtained before implementation of the amended procedures. It is also the 
responsibility of the Investigator to provide the IRB/EC with any SAE or Investigational New 
Drug safety reports. A copy of the ICF approved by the IRB/EC must be forwarded to Enanta 
Pharmaceuticals, Inc. for regulatory purposes. 
12.1.3 Written Informed Consent 
The Investigator or designee must explain to each subject the purpose and nature of the study, 
the study procedures, the possible adverse effects, and all other elements of consent as defined in 
21 CFR Part 50, and other applicable national and local regulations governing informed consent.  
For this study, there will be two ICFs. Details on these are provided in Section 7.1.1. Each 
subject must provide a signed and dated ICF prior to enrollment into this study. Signed consent 
forms must remain in each subject’s study file and be available for verification by study monitors 
at any time. In accordance with individual local and national subject privacy regulations, the 
Investigator or designee must explain to each subject prior to Screening that for the evaluation of 
study results, the subject’s protected health information obtained during the study may be shared 
with Enanta Pharmaceuticals, Inc. and its designees, regulatory agencies, and IRBs/ECs. As the 
study Sponsor, Enanta Pharmaceuticals, Inc. will not use the subject’s protected health 
information or disclose it to a third party without applicable subject authorization. It is the 
Investigator’s or designee’s responsibility to obtain written permission to use protected health 
information from each subject, or if appropriate, the subject’s legal guardian. If a subject or 
subject’s legal guardian withdraws permission to use protected health information, it is the 


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Investigator’s responsibility to obtain the withdrawal request in writing from the subject or 
subject’s legal guardian and to ensure that no further data will be collected from the subject. Any 
data collected on the subject prior to withdrawal will be used in the analysis of study results.  
12.1.4 Investigator Compliance 
No modifications to the protocol should be made without the approval of both the Investigator 
and Enanta Pharmaceuticals, Inc. Changes that significantly affect the safety of the subjects, the 
scope of the investigation, or the scientific quality of the study (ie, efficacy assessments) will 
require IRB/EC notification prior to implementation, except where the modification is necessary 
to eliminate an apparent immediate hazard to human subjects.  
If circumstances require an immediate departure from protocol procedures, the Investigator will 
contact Enanta Pharmaceuticals, Inc. and/or its designee to discuss the planned course of action. 
Contact should be made prior to the implementation of any changes when possible. Any 
departures from protocol must be fully documented in the source documents and reported to 
Enanta Pharmaceuticals, Inc. or its designee and the IRB/EC as required.  
12.2 Data Collection 
Study data for each randomized subject will be entered into an eCRF by site staff. It is the 
Investigator’s responsibility to ensure the accuracy, completeness, clarity, and timeliness of the 
data reported in the subject’s eCRF. Source documentation supporting the eCRF data should 
indicate the subject’s participation in the study and should document the dates and details of 
study procedures, AEs, other observations, and subject status. The Investigator or designated 
representative should complete the eCRF as soon as possible after information is collected. An 
explanation should be provided for all missing data. 
After the subject has completed the study, the Investigator must review and sign the signature 
page of the eCRF indicating that he or she has reviewed the completed eCRF and pertinent 
clinical data for that subject and that, to the best of his or her knowledge, all data recorded in the 
eCRF accurately reflects the subject’s clinical performance in the study.  
Sites are responsible for abiding by the rules and regulations of their IRB/EC for recording and 
reporting protocol deviations. All deviations reported to the IRB/EC must be reported to Enanta 
Pharmaceuticals, Inc. and/or their designee and recorded as deviations as appropriate in the 
eCRF. 
12.3 Study Monitoring 
Representatives of Enanta Pharmaceuticals, Inc. or its designee will monitor this study until 
completion. Monitoring will be conducted through both on-site and remote visits with the 
Investigator and site staff as well as any appropriate communications by mail, fax, email, or 
telephone. The purpose of monitoring is to ensure compliance with the protocol and the quality 
and integrity of the data. The Study Monitor will ensure that the investigation is conducted 


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according to protocol and regulatory requirements, and as described in the Study Monitoring 
Plan. 
Every effort will be made to maintain the anonymity and confidentiality of all subjects during 
this clinical study. However, because of the experimental nature of this treatment, the 
Investigator agrees to allow the IRB/EC, representatives of Enanta Pharmaceuticals, Inc., its 
designated agent, and authorized employees of the appropriate regulatory agencies to inspect the 
facilities used in this study and, for purposes of verification, allow direct access to the hospital or 
study site records of all subjects enrolled into this study. A statement to this effect will be 
included in the ICF authorizing the use of protected health information. 
12.4 Quality Assurance 
At its discretion, Enanta Pharmaceuticals, Inc. or its designee may conduct a quality assurance 
audit of this study. If such an audit occurs, the Investigator will give the auditor direct access to 
all relevant documents and will allocate his or her time and the time of his or her site staff to the 
auditor as required. In addition, regulatory agencies may conduct an inspection of this study. If 
such an inspection occurs, the Investigator will notify the Sponsor and 
 and will allow the 
inspector direct access to all source documents, eCRFs, and other study documentation for 
source data check and/or on-site audit inspection.  
12.5 Retention of Records 
The site will retain a copy of all study records in a safe, secure, and accessible location for a 
minimum of 2 years after notification by Enanta Pharmaceuticals, Inc. that the investigations of 
EDP-938 have been discontinued or for 2 years following marketing approval of the drug, after 
which time, Enanta Pharmaceuticals, Inc. will be contacted for instructions on the disposition of 
study materials. Study records will contain all of the appropriate documents as detailed in 
Section 8.0 of the ICH-GCP E6.  
12.6 Information Disclosure 
12.6.1 Confidentiality 
Subject names will remain confidential and will not be supplied to Enanta Pharmaceuticals, Inc. 
or its designee. Only subject number, subject initials, and birth date or age will be recorded on 
the eCRF. If the subject name appears on any other document collected (eg, unit discharge 
summary), it must be obliterated before the document is transmitted to Enanta Pharmaceuticals, 
Inc. or its designee. All study findings will be stored in electronic databases. As indicated in the 
ICF, subjects will give permission for representatives of the Sponsor, regulatory authorities, and 
the IRB/EC to inspect their medical records to verify the information collected. Subjects will be 
informed that all personal information made available for inspection will be handled in the 
strictest confidence and in accordance with local data protection/privacy laws. 


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Individual subject medical information obtained during this study is confidential and its 
disclosure to third parties other than those mentioned in the preceding paragraph is prohibited. 
Medical information obtained during this study may be provided to the subject’s personal 
physician or other appropriate medical personnel when required in connection with the subject’s 
continued health and welfare and with the subject’s prior knowledge and permission. 
12.6.2 Publication Policy 
It is the intention of Enanta Pharmaceuticals, Inc. to publish the results of this study in their 
entirety within a reasonable period of time following conclusion of the study. The Sponsor will 
determine when and where data will be first disclosed.  
All information generated from this study is the proprietary property of Enanta Pharmaceuticals, 
Inc. Enanta Pharmaceuticals, Inc. reserves the right, among other things, to: 
• Modify or amend study material to ensure that no confidential or proprietary information 
is disclosed 
• Ensure that the reported data are factually correct 
• Utilize the information generated from or as a result of this study in any manner it deems 
appropriate, including but not limited to regulatory submissions, annual reports, and other 
scientific or business affairs of the company 
• Modify the publication or disclosure or delay it a sufficient time to allow Enanta 
Pharmaceuticals, Inc.to seek patent protection of any invention contained therein 
 


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13. 
REFERENCES 
Ahmad A, Sanderson K, Dickerson D, et al. EDP-938, a novel, non-fusion replication inhibitor of 
respiratory syncytial virus: final results of a Phase 1 study in healthy subjects (HS). Poster session 
presented at: 11th International Respiratory Syncytial Virus Symposium; 2018 Oct 31-Nov 4, Asheville, 
NC. 
Dong Y, Peng C-YJ. Principled missing data methods for researchers. SpringerPlus. 2013;2:222. 
Available at: https://springerplus.springeropen.com/track/pdf/10.1186/2193-1801-2-222. Accessed 
21 Aug 2019.  
Falsey AR, Hennessey PA, Formica MA, et al. Respiratory syncytial virus infection in elderly and 
high-risk adults. N Engl J Med. 2005;352(17):1749-59. 
Hall CB, Weinberg GA, Iwane MK, et al. The burden of respiratory syncytial virus infection in young 
children. N Engl J Med. 2009;360(6):588-98. 
Matthews JN, Altman DG, Campbell MJ, et al. Analysis of serial measurements in medical research. 
BMJ. 1990; 300(6719): 230-5. 
Nair H, Nokes DJ, Gessner BD, et al. Global burden of acute lower respiratory infections due to 
respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 
2010;375(9725), 1545-55. 
 
 
 
 
 
Randolph AG, Wang EE. Ribavirin for respiratory syncytial virus lower respiratory tract infection. A 
systematic overview. Arch Pediatr Adolesc Med. 1996;150(9):942-7. 
Rockwood K, Song X, MacKnight C, et al. A global clinical measure of fitness and frailty in elderly 
people. CMAJ. 2005;173(5):489-95.  
Shi T, McAllister DA, O’Brien KL, et al. Global, regional, and national disease burden estimates of 
acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a 
systematic review and modelling study. Lancet. 2017;390(10098):946-58. 
Shook BC, Lin K. Recent advances in developing antiviral therapies for respiratory syncytial virus. Top 
Curr Chem (Cham); 2017:375(2):40. 
 




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a Day 1 assessments to be performed in randomized subjects.  
b Subjects who discontinue treatment early (ie, prior to completing 5 days of dosing) or the study early (ie, prior to Day 14) should return to 
the study site within 24 hours and no more than 48 hours later to complete the EOS procedures. 
c Visit assessments may be completed at the study site or by a study nurse via a home visit, if feasible; refer to the SPM for details. It is 
anticipated that every reasonable effort will be made to ensure that subjects return to the site for the Day 3 and Day 5 visits.  
d Informed consent must be obtained prior to conducting any study-specific assessments. For this study, there will be two ICFs. Subjects 
will review and sign the Rapid Viral Screen ICF prior to RSV and influenza screening. Subjects whose swab sample tests positive for 
RSV and negative for influenza virus may proceed for further screening. Such subjects will be required to sign the full study ICF prior to 
performing any further study-specific assessments. After signing the full study ICF, subjects will undergo further screening procedures to 
determine study eligibility. 
e A nasal (or NP) swab sample will be collected to obtain respiratory secretions for a rapid diagnostic screen for RSV and influenza A/B. 
f Subjects who sign the full study ICF and whose swab sample test results are positive for RSV and negative for influenza will be screened 
for SARS-CoV-2, using a rapid diagnostic test. 
g Vital signs include heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. Vital signs will be measured 
after the subject has been supine for a minimum of 5 minutes. 
h A full physical examination will be performed at Screening. Any subsequent physical examinations performed at the discretion of the 
Investigator will be targeted to new signs and symptoms, including specific assessments of any changes from previous status. 
i Height will be documented at Screening only. Body mass index will be calculated at Screening (to assess eligibility) according to the 
following equation: BMI = weight (kg)/height (m)2. 
j Pulse oximetry measurements should only be performed in subjects with asthma or COPD. 
k Pregnancy testing will be performed in female subjects of childbearing potential. A urine pregnancy test will be performed at Screening 
and at the EOS Visit. In addition, on Day 1, blood will be collected for a serum pregnancy test to be performed by the central laboratory. 
The screening urine pregnancy test results will be used to qualify subjects at study entry. Refer to Section 8.4.2 for pregnancy testing 
requirements for postmenopausal females. 
l Follicle-stimulating hormone should be tested in postmenopausal females. Refer to Section 8.4.2. 
m Clinical laboratory tests include chemistry, hematology, and urinalysis. See Section 8.4 and Table 2 for details regarding Day 1 sample 
collection and evaluations for the local and central laboratory(ies). 
n Subjects who meet all inclusion criteria and none of the exclusion criteria to the satisfaction of the Investigator, including the screening 
ECG and the screening urine pregnancy test, will be eligible to enter the study and will be randomized 1:1 to receive 800 mg of EDP-938 
or placebo. Subject randomization will be stratified by the presence or absence of asthma/COPD. 
o Eligible subjects will receive an electronic data capture handheld device (ERT® eCOA Handheld eDiary) on Day 1 and will return the 
device to the study site at the EOS Visit. Refer to Section 7.1.2 for additional details. 
p The RSV symptom diary will be self-completed by subjects twice daily at the same times each day ±2 hours as an eCOA. If a subject 
plans to take acetaminophen within 2 hours of the scheduled RSV symptom diary completion, then the RSV symptom diary should be 
completed immediately before the subject takes acetaminophen or 4 hours after taking acetaminophen. 
 
 
 
 
s Study drug (EDP-938 or placebo) should be administered at the study site on Days 1 and 5. On Day 5, the study site visit should be 
scheduled close to the time that the subject normally takes the study drug so that dosing can occur at the site. From Day 1, subjects will 
electronically record the time and date that each dose is taken. See Section 5.7 for additional dosing details. 
t Study drug accountability by tablet count and review of the electronic dosing record completed by the subjects. 
u On Day 1, collect one postdose plasma PK sample, at least 1 hour after dosing or right before the subject leaves the site, whichever is later. 
On Day 3, collect one plasma PK sample at the same approximate time as that of the NP swab collection. On Day 5, collect one predose 
PK sample. If the subject takes the study drug prior to the study site visit, a PK sample should be taken at the same approximate time as 
that of the NP swab collection. See Section 5.7 and Section 8.6 for additional details. 
v At the EOS Visit, a PK sample is only required for subjects who discontinue the study before the last dose of study drug is taken. The PK 
sample should be collected at the same approximate time as that of the NP swab collection. 
w Acetaminophen use will be permitted only for the relief of fever or pain. Subjects will electronically record the date and time of any 
acetaminophen use. See Section 5.8 for additional details on acetaminophen use.