Safety, Pharmacokinetics and Antiviral Activity of EDP-938 against RSV
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-938 Against Respiratory Syncytial Virus Infection in the Virus Challenge Model.
IRAS ID
251255
Contact name
Sungeen Patel Hill
Contact email
Sponsor organisation
ENANTA Pharmaceuticals, Inc
Eudract number
2018-001878-21
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 9 months, 15 days
Research summary
RSV causes serious respiratory problems in infants the elderly. There is currently no available vaccine, and the only licensed antiviral(ribavirin) is rarely used due to its limited efficacy and side effects. EDP-938 is a novel drug that has been developed as a potential treatment for RSV infection.
This is a randomised, phased 2a, double-blind study to evaluate the safety and efficacy of EDP-938 and also to assess how the human body deals with the drug (this is known as pharmacokinetics) in a virus challenge model. Healthy males and females aged 18 to 55 will be inoculated with the virus in an established experimental quarantine unit and administered multiple doses of EDP-938 or a placebo (dummy drug) in the form of oral suspension.
The study will be conducted in a single site and will include multiple quarantine sessions where up to 198 subjects will be admitted in 2 parts:
- Part 1:
114 subjects will be randomised into 1 of 3 treatment groups:
Group 1: 38 subjects will receive Placebo twice daily for a total of 10 doses.
Group 2: 38 subjects will receive a loading dose of 500mg of EDP-938 followed by 300 mg dose twice daily for a total of 10 doses.
Group 3: 38 subjects will receive a daily 600mg dose followed by a placebo dose at 12hours interval for a total of 10 doses.
- Part 2:
•Up to 84 subjects in total will be enrolled following an analysis of Part 1. Up to 63 subjects will complete dosing with EDP-938 and up to 21 subjects will complete dosing with placebo. The doses to be administered, dosing regimen, duration of dosing (up to 7 days), number of doses per day,timing of initiation of dosing will be defined based on emerging PK, virology, clinical symptom score, and safety data from Part 1.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
18/YH/0328
Date of REC Opinion
5 Oct 2018
REC opinion
Further Information Favourable Opinion