Safety, PK & PD of UCB7665 IV/SC infusion as SAD in healthy subjects

• Research type

  Research Study

• Full title

  A subject-blind, investigator-blind, randomized, placebo-controlled, first-in-human study evaluating the safety, pharmacokinetics and pharmacodynamics of single ascending intravenous and subcutaneous doses of UCB7665 in healthy subjects

• IRAS ID

  155582

• Contact name

  Annelize Koch

• Contact email

  annelize.koch@parexel.com

• Sponsor organisation

  UCB Celltech, UK Registered Branch of UCB Pharma SA

• Eudract number

  2013-005469-38

• Duration of Study in the UK

  0 years, 7 months, 4 days

• Research summary

  The new medicine tested in this study is a compound called UCB7665. The Sponsor is developing the study drug for treating diseases of the immune system, including myasthenia gravis, pemphigus vulgaris, neuromyelitis optica and Guillain-Barré Syndrome. The immune system works to protect the body against infection but sometimes it can be overactive which can result in immune diseases (the immune system causing diseases by damaging one's own body).

  The main purpose of the study is to:
  • Look at the effects of the study drug (if it causes changes in the body).
  • Look at the side effects of the study drug (changes in the body that are not intended and unwanted).
  • Look at the blood levels of the drug and how quickly the body gets rid of it.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  14/LO/0806

• Date of REC Opinion

  22 Jul 2014

• REC opinion

  Further Information Favourable Opinion