Study to Assess the Immune Response to C13013

• Research type

  Research Study

• Full title

  A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single Dose Study in Healthy Subjects to Determine the Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab

• IRAS ID

  80977

• Sponsor organisation

  Millennium Pharmaceuticals Inc

• Eudract number

  2011-001874-24

• Research summary

  This study will look at the effects of vedolizumab on the body's ability to develop immunity to a hepatitis B vaccine and a cholera vaccine's well as the types of defenses the body creates. This study will also look to answer the following questions:1.What are the actions or effects of vedolizumab on the body? This process is called pharmacodynamic analysis.2.How is vedolizumab taken up (absorbed), broken down (metabolized), and eliminated (excreted) by the body? This process is called pharmacokinetic analysis.3.What side effects does a single dose of vedolizumab have in healthy individuals?

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0092

• Date of REC Opinion

  8 Aug 2011

• REC opinion

  Further Information Favourable Opinion