FKB238 - first doses in humans & comparison with Avastin
Research type
Research Study
Full title
A randomised, double-blind, single-dose study to compare pharmacokinetic characteristics and safety of FKB238 with those of Avastin in healthy male subjects (HMR code 14-009)
IRAS ID
163882
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
Fujifilm Kyowa Kirin Biologics Co., Ltd.
Eudract number
2014-002933-73
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The study medicine, FKB238, is a new form of an existing medicine called Avastin, which is prescribed by doctors to treat many different types of cancer and is mainly used in combination with chemotherapy. Avastin is available in Europe (the EU), the USA, and many other countries. It contains a protein called a ‘monoclonal antibody’, which is made specifically for use in humans. FKB238 is being developed as a potentially cheaper alternative to Avastin. If this study and other investigations show that FKB238 and Avastin have similar effects and blood levels, then FKB238 might be approved for use, allowing a useful cancer medicine to be made more widely available.
Although Avastin has been used by many patients throughout the world, FKB238 has never been given to humans before.We’ll give up to 180 healthy men, aged 18–55 years, a single dose of FKB238 or Avastin, by infusion (slow injection) into a vein in the arm. To confirm any important differences, we’ll compare FKB238 to 2 different forms of Avastin. So, each volunteer will receive either: FKB238, Avastin from the EU, or Avastin from the USA (about a third of volunteers will receive each treatment).
Participants will take up to 18 weeks to finish the study. After an initial screening visit, they’ll stay on the ward for 8 nights in a row. Then they’ll make 6 outpatient visits.
The study will take place at 1 centre in London. A pharmaceutical company (Fujifilm Kyowa Kirin Biologics Co., Ltd.) is funding the study.
REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/1652
Date of REC Opinion
22 Oct 2014
REC opinion
Favourable Opinion