Phase 2a trial of MDT-637 in healthy subject challenged with RSV.
Research type
Research Study
Full title
A Phase 2a Randomised, Double-Blind, Placebo-Controlled Repeat Dose Trial of the Activity of MDT-637 in Healthy Subjects Challenged with Respiratory Syncytial Virus (RSV)
IRAS ID
102542
Contact name
Bryan Murray
Contact email
Sponsor organisation
MicroDose Therapeutx
Eudract number
2012-001107-20
Research summary
A randomised, double blind, placebo (dummy) controlled study assessing the effects of the study drug using a combination inhaler device MDT-637, on healthy volunteers exposed to Respiratory Syncytial Virus (RSV) during a 15 day quarantine period.
Volunteers will be screened to identify approximately 96 volunteers who will be dosed with RSV-A (Memphis 37b) strain, and monitored by 24 hour medical and nursing staff.
Post informed consent, volunteers have a blood sample taken to assess their previous exposure to RSV (via a blood test called a RSV neutralisation assay)within 160 days of the date of inoculation. Volunteers who have levels that indicate they have not been previously exposed to RSV to the extent inoculation would secure adequate infection rates, will attend for Study Specific Screening.
Volunteers will be asked to attend the Quarantine unit on Day -2 (Day -1 to Day 0 am) prior to inoculation for further screening and if they do not meet all the eligibility criteria as specified in the protocol they would be excluded at this stage.
Eligible volunteers would be inoculated with RSV on Day 0, followed by allocation of randomisation number. Subjects will be randomised to either active or placebo study medication in a blinded fashion. Dosing will commence between Days 1 to 5 when it is confirmed by nasal wash they are infected with RSV. Any subject not confirmed infected with RSV on Day 5 (am) will also commence dosing. Each subject will receive 21 doses in total at a rate of 3 per day.
Subjects will remain in quarantine for a total of 15 days, (12 days post inoculation). It is rare for a subject to stay longer than the specified period however they may remain for additional days at doctors discretion if still symptomatic.
After discharge from quarantine, subjects will attend a follow up visit at approximately Day 28.
REC name
London - City & East Research Ethics Committee
REC reference
12/LO/0677
Date of REC Opinion
24 Jul 2013
REC opinion
Further Information Favourable Opinion