RSV challenge study to examine JNJ-53718678 in healthy subjects
Research type
Research Study
Full title
A phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the antiviral activity, safety and pharmacokinetics of repeated doses of orally administered JNJ-53718678 against Respiratory Syncytial Virus infection in the virus challenge model in healthy adult subjects.
IRAS ID
174969
Contact name
Samuel Israel
Contact email
Sponsor organisation
Janssen-Cilag BV
Eudract number
2014-005041-41
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 5 months, 0 days
Research summary
This is a human challenge study in which healthy adults will be inoculated with RSV-A Memphis 37b virus, and the antiviral activity, pharmacokinetics, effect on clinical symptoms of RSV infection, safety and tolerability of JNJ-53718678 after repeated dosing will be evaluated.
RSV infection is a respiratory illness caused by a virus, anyone can become infected. Typical symptoms resemble common cold in adults and older children but can result in serious problems in young babies, including pneumonia and severe breathing problems. The Sponsor has developed the study drug, a RSV-specific fusion inhibitor, and results from this study may be useful in developing a new therapy for RSV
infection.There are three sequential phases to the study: screening, quarantine & follow-up.
Subjects will attend a screening visit up to 54 days (Study Day -56 to Study Day -3) before quarantine where volunteers will be asked to complete an informed consent and undergo scheduled screening assessments to determine their eligibility.
If volunteers fulfil the eligibility criteria they will be invited to attend the quarantine phase which is two days (Day -2 and Day -1). During this phase volunteers will be admitted to the purpose built quarantine facility in London. Further assessments will be undertaken to ensure subject suitability is maintained from initial visit. 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 once daily for 7 days in quarantine cohort 1, and up to 7 days in cohort 2. The dose to be administered, number of doses per day in cohort 2 will be defined based on the data from cohort 1.Volunteers will be regularly monitored and remain in the quarantine unit for 13 days after inoculation or longer if deemed necessary by the study doctor.
Following discharge (Day 13), volunteers would be asked to return for two follow up visits on Day 15(± 1 day)and Day 28(± 3 days)for well-being, ongoing symptoms and adverse events.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
15/EE/0110
Date of REC Opinion
24 Apr 2015
REC opinion
Further Information Favourable Opinion