First time in man dual action antibody study

• Research type

  Research Study

• Full title

  An exploratory FTIH study investigating the pharmacokinetics, immunogenicity, safety and tolerability of GSK2434735 administered as a single low dose in healthy male subjects.

• IRAS ID

  85099

• Contact name

  Annelize Koch

• Eudract number

  2011-004541-41

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  GSK2434735 is a new format that has not yet been tested in humans. It is a bispecific antibody that attaches to interleukins 4 and 13 and stops them working. Interleukins help the body fight particular infections and are also involved in other conditions such as asthma. In general, for monoclonal antibodies the PK profile or length of time that the drug stays detectable in the human??s bloodstream can usually be estimated from the PK profile in the monkey. Since GSK2434735 is a new type of molecule, we do not know if the monkey will be a good model to predict the human PK profile. We therefore plan to measure the length of time that GSK2434735 stays detectable in the blood stream in a healthy people which will allow us to decide if the monkey is a good animal model for predicting the PK profile in man. Therefore the main aims of this exploratory study are to see if the blood levels in humans can be predicted by monkeys and to find out if man produces antibodies to the drug itself. This first-in-human exploratory study will also assess the safety, disposition and the general effects of GSK2434735 in healthy men. Ten healthy men will be recruited for this open label study. Each dosing session will last for 3« days with overnight stays at the clinical unit. Each volunteer will receive a single low dose of GSK2434735 given by the intravenous or subcutaneous route. The blood levels and safety of GSK2434735 will be monitored closely. After dosing the volunteers will attend the clinic for six follow-up visits to Day 42 then they will receive a final follow-up telephone call at Day 84.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  12/EE/0012

• Date of REC Opinion

  6 Feb 2012

• REC opinion

  Further Information Favourable Opinion