A Phase 2a study to evaluate the efficacy of EDP-323 against RSV in a virus challenge model.
Research type
Research Study
Full title
A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered EDP-323 Against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adults
IRAS ID
1007761
Contact name
Timothy Abrahamsen
Contact email
Sponsor organisation
Enanta Pharmaceuticals, Inc.
Research summary
The purpose of this research is to test the effects of an experimental drug called EDP-323 (the ‘study drug’) that may be useful in treating patients infected with Respiratory Syncytial Virus (RSV-A Memphis 37b). RSV infection can cause a range of respiratory disease such as bronchitis and lower respiratory infections including bronchiolitis and pneumonia. These serious illnesses affect infants, certain adults who are older (especially if they are ≥65), have chronic heart or lung disease or have a weakened immune system. This study is funded by ENANTA Pharmaceuticals, Inc. and will take place in hVIVO facilities in London. To test the study drug, we infect healthy participants with a study virus in one of our Quarantine residential facilities. Up to 125 participants will take part in the study which will be split into two parts. Each participant will be in the study for about 4 months or 16 weeks from Screening to the last clinic visit.
The study will consist of 3 phases:
- Screening phase: Screening will occur between Day -90 to Day -2/-1. When historical screening data collected through the hVIVO generic screening process is used for screening, the study-specific ICF will be obtained at the first study-specific visit from each participant before any study-specific procedures are performed.
- Quarantine phase: Participants will stay in the quarantine unit for approximately 15 days. One to two days prior to the day of inoculation with RSV, participants will be admitted to quarantine where their eligibility will be reassessed before inoculation on Day 0. Participants will undergo a range of clinical assessments and safety monitoring for the entirety of their stay in quarantine. Participants will be discharged from the quarantine unit on from Day 12 (an extended stay may be required).
- Follow-up phase: Final follow-up visit 28 days (±3 days) after the day they receive the virus. Their symptoms will be reassessed, and a complete safety examination performed.REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0636
Date of REC Opinion
12 Oct 2023
REC opinion
Further Information Favourable Opinion