First in human study of anti-IL7-R monoclonal antibody (I7R116702)

• Research type

  Research Study

• Full title

  A First Time in Human study exploring preliminary safety, tolerability, pharmacokinetics and pharmacodynamics of GSK2618960 in healthy volunteers and patients with relapsing remitting multiple sclerosis.

• IRAS ID

  119657

• Contact name

  Joseph Cheriyan

• Eudract number

  2012-005501-43

• ISRCTN Number

  N//A

• Clinicaltrials.gov Identifier

  N//A

• Research summary

  Multiple sclerosis (MS) is a disease where patients?? own immune system cells, called lymphocytes, attack the brain and spinal cord causing damage. GlaxoSmithKline (GSK) is developing GSK2618960 as a potential medicine for treatment of MS as it blocks the IL7R, which is involved in a pathway that is crucial to the lymphocytes causing multiple sclerosis. This study is the first time GSK2618960 will be tested in humans, assessing safety and tolerability following single and repeat doses in healthy volunteers and MS patients. It will also measure the levels of GSK2618960 in blood (pharmacokinetics/PK), and its effects on some blood tests (pharmacodynamics/PD). In Part A, 5 groups of 4 to 8 volunteers (total 24) will receive two ascending doses of either GSK2618960 or placebo, over a few weeks. Sufficient time for complete washout of the drug will be allowed. In Part B, 24 healthy volunteers will receive repeated doses of either GSK2618960 or placebo. Parts A and B will be single-blind (investigator on site and volunteer are unaware of what drug is being given, but the study team are aware). In Part C, patients with MS will receive repeated doses of GSK2618960. Part C will be open-label, that is both patient and investigator will know GSK2618960 is being administered. Patients will also undergo interval MRI scanning to determine effects on disease activity. The doses for Parts A, B and C will be decided after review of safety, PK and PD during and after each group. All study subjects will be admitted to a specialist clinical research unit with adequate safety and compliance facilities for dosing of the drug. The study will finish once the final patient in Part C has undergone the last follow-up appointment, approximately 26 weeks after entering the study. Part C is planned to commence in 2014.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  13/SC/0030

• Date of REC Opinion

  1 Mar 2013

• REC opinion

  Further Information Favourable Opinion