Safety, Pharmacokinetics and Antiviral Activity of RV521 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 RV521 Against Respiratory Syncytial Virus Infection In The Virus Challenge Model
IRAS ID
227714
Contact name
John Efthimiou
Contact email
Sponsor organisation
ReViral Limited
Eudract number
2017-001282-24
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
This is a Phase 2a, double blind study in which healthy adults will be infected with the Respiratory Syncytial Virus (RSV). The volunteers will then be orally administered the study drug; RV521 or placebo (dummy drug). The study will evaluate the safety and antiviral activity of the study drug and assess how the human body deals with the study drug (this is called Pharmacokinetics).
Volunteers could be entered in 2 cohorts (groups), where one cohort will receive a 200mg dose of the study drug or placebo and the other cohort will receive 350mg of the study drug or placebo. Each subject will receive 10 administrations of the study drug or placebo (12 hours apart). Up to 66 subjects will be examined across the 2 cohorts.
RSV is one of the viruses that causes the common cold, but it can result in serious problems in infants, the elderly and anyone with a low resistance to infection. The Sponsor has developed the study drug, which is a selective inhibitor of RSV infection.
The study consists of 3 parts:
1) Screening will take place up to 90 days before quarantine where volunteers will be asked to complete an informed consent and undergo scheduled assessments to determine their eligibility.
2) The Quarantine (Challenge) Phase is where volunteers who are eligible will be admitted to the purpose built quarantine facility in London. Further assessments will be undertaken to ensure subject suitability. Once confirmed, volunteers will be inoculated with RSV on Day 0. Once infection is confirmed, subjects will be randomly selected for treatment with study drug or placebo (200mg or 350mg) twice daily for 5 days.
3) Following discharge (Day 12), volunteers will be asked to return for a follow up visit on Day 28(± 3 days) to assess their wellbeing, and any ongoing symptoms.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0167
Date of REC Opinion
13 Jun 2017
REC opinion
Further Information Favourable Opinion