CNTO3157 in Healthy and Asthmatic volunteers inoculated with HRV16, v1

• Research type

  Research Study

• Full title

  A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating CNTO 3157 in Healthy Normal and Asthmatic Subjects Inoculated with Human Rhinovirus Type 16

• IRAS ID

  109896

• Contact name

  Sebastian Johnston

• Sponsor organisation

  Janssen Cilag International NV

• Eudract number

  2011-005369-19

• Research summary

  For People'suffering with Asthma or COPD, catching a 'common cold' can make their symptoms worse, this is known as exacerbation. In some cases exacerbation can be bad enough to require hospital treatment. A therapy that could prevent, or reduce the effect of, exacerbations could be of medical benefit to patients suffering with Asthma/COPD. This is a phase 1b study designed to test the safety and efficacy of a new monoclonal antibody drug, in volunteers deliberately infected with the common cold virus. The study will be split into 2 parts. First (Part 1), 12 healthy volunteers will be recruited. Following a safety review a further (Part 2) 60 asthmatic volunteers will be recruited. The study is designed to see if the mediction is safe and if volunteers who are given placebo (fake medication) have worse respiratory manifestations (e.g. coughing, wheezing, difficulty breathing etc) than those given study drug when deliberately infected with a 'common cold'. Volunteers will be in the study for up to 13 weeks (Healthy Volunteers) and 16 weeks (Asthmatic Volunteers). During this time they will need to visit the trial centre up to 16 times. At the study visits a number of routine health checks will be performed, blood samples taken, specific repiratory tests will be done and patient questionnaires to be completed. Study drug (or placebo) is administered by an intravenous infusion. Infecting volunteers with the 'common cold' will be done by nasal inoculation (squirting manufactured virus into the nose). Janssen R&D is sponsoring the study. In the UK the study is planned to be conducted within 4 specialist respiratory centres and/or commercial Phase 1 units located in London, Manchester, Scotland and Northern Ireland. There are other trial sites planned globally.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  12/LO/1343

• Date of REC Opinion

  10 Oct 2012

• REC opinion

  Further Information Favourable Opinion