FKB327 – first doses in humans & comparison with Humira

• Research type

  Research Study

• Full title

  A randomized, double-blind, single-dose study to compare pharmacokinetic characteristics and safety of FKB327 with those of Humira in healthy subjects (HMR code 12-021)

• IRAS ID

  119502

• Contact name

  Elizabeth Tranter

• Sponsor organisation

  Fujifilm Kyowa Kirin Biologics Co. Ltd

• Eudract number

  2012-005140-23

• Research summary

  FKB327 is an experimental treatment for autoimmune diseases, such as rheumatoid arthritis, in which the body??s immune system attacks its own organs. We hope that FKB327 will block a substance called TNF-alpha, which is involved in the immune response, and prevent damage to normal tissues. FKB327 hasn??t been given to humans before, but it??s a new form of an existing medicine called Humira, which is prescribed by doctors to treat autoimmune diseases. Humira contains a large protein called a ??monoclonal antibody??. FKB327 is being developed as a ??biosimilar?? medicine to Humira, which means that it contains a similar antibody as Humira. We??re doing this study to compare side effects and blood levels of FKB327 and Humira. We'll give 120 healthy men, aged 18??45 years, a single dose of FKB327 or Humira, by injection under the skin. Participants will take up to 13 weeks to finish the study. After an initial screening visit, they??ll stay on the ward for 9 nights in a row. Then they??ll make 7 outpatient visits. The study will take place at one centre in London. We'll recruit healthy participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites. A pharmaceutical company Fujifilm Kyowa Kirin Biologics Co Ltd is funding the study.

• REC name

  Scotland A REC

• REC reference

  12/SS/0220

• Date of REC Opinion

  17 Dec 2012

• REC opinion

  Favourable Opinion