A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model
A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered EDP-938 Against Respiratory Syncytial Virus Infection in the Virus Challenge Model.
1 other identifier
interventional
179
1 country
1
Brief Summary
A randomised, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-938 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to compare the antiviral effect of EDP-938 compared to a placebo control in the respiratory syncytial virus challenge model.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2018
CompletedFirst Posted
Study publicly available on registry
October 2, 2018
CompletedStudy Start
First participant enrolled
October 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2019
CompletedResults Posted
Study results publicly available
May 3, 2022
CompletedMay 3, 2022
August 1, 2019
12 months
September 28, 2018
February 24, 2022
April 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load
Measured in nasal washes by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in participants inoculated with respiratory syncytial virus-A (RSV-A) Memphis 37b.
Twice daily on Day 2 through Day 11 and once on Day 12
Secondary Outcomes (23)
Area Under the Curve (AUC) of Total Symptom Score
Three times daily on Day 0 to Day 11, once on Day 12
Peak Total Symptom Score
Day 2 to Day 12
Total Symptom Score
Day 2 to Day 9
Time to Peak Total Symptom Score
Day 2 to Day 12
Time to Resolution From Peak Total Symptom Score
Day 2 to Day 12
- +18 more secondary outcomes
Study Arms (6)
EDP-938 Arm A
EXPERIMENTALSubjects will take EDP-938 Dose 1 oral suspension for 5 days
EDP-938 Arm B
EXPERIMENTALSubjects will take EDP-938 Dose 2 oral suspension for 5 days
Placebo Arm C
PLACEBO COMPARATORSubjects will take matching placebo oral suspension for 5 days
EDP-938 Arm D
EXPERIMENTALSubjects will take EDP-938 Dose 3 oral suspension for 5 days
EDP-938 Arm E
EXPERIMENTALSubjects will take EDP-938 Dose 4 oral suspension for 5 days
Placebo Arm F
PLACEBO COMPARATORSubjects will take matching placebo oral suspension for 5 days
Interventions
Eligibility Criteria
You may qualify if:
- An informed consent document signed and dated by the subject
- Age 18 to 55 years, inclusive
- In good health with no history of major medical conditions
- A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m\^2 and ≤ 30kg/m\^2
You may not qualify if:
- Pregnant or nursing females
- Acute or chronic medical illness
- Abnormal lung function
- Positive for human immunodeficiency virus (HIV), active hepatitis A, B or C test
- Nose or nasopharynx abnormalities
- Receipt of any investigational drug within 3 months prior to the planned date of viral challenge/first dose of study drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Enanta Pharmaceuticals, Inclead
- hVIVO Services Limitedcollaborator
Study Sites (1)
hVIVO Services Limited (hVIVO)
London, United Kingdom
Related Publications (2)
Levene RE, DeVincenzo J, Conery AL, Ahmad A, Or YS, Rhodin MHJ. EDP-938 Has a High Barrier to Resistance in Healthy Adults Experimentally Infected with Respiratory Syncytial Virus. J Infect Dis. 2025 Feb 20;231(2):e290-e298. doi: 10.1093/infdis/jiae471.
PMID: 39441691DERIVEDAhmad A, Eze K, Noulin N, Horvathova V, Murray B, Baillet M, Grey L, Mori J, Adda N. EDP-938, a Respiratory Syncytial Virus Inhibitor, in a Human Virus Challenge. N Engl J Med. 2022 Feb 17;386(7):655-666. doi: 10.1056/NEJMoa2108903.
PMID: 35172056DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Guy De La Rosa, MD, Senior Medical Director, Infectious Diseases
- Organization
- Enanta Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Enanta Pharmaceuticals, Inc
Enanta Pharmaceuticals, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2018
First Posted
October 2, 2018
Study Start
October 15, 2018
Primary Completion
September 30, 2019
Study Completion
October 18, 2019
Last Updated
May 3, 2022
Results First Posted
May 3, 2022
Record last verified: 2019-08