A PK study of a New Similar Biological Product to Avastin®

• Research type

  Research Study

• Full title

  A randomized, single-blind, single-dose, 3-arm, parallel group study to determine the pharmacokinetics of ABP 215 and bevacizumab (Avastin®) in healthy male subjects

• IRAS ID

  103092

• Contact name

  Muna Albayaty

• Sponsor organisation

  Amgen Inc.

• Eudract number

  2012-000783-18

• ISRCTN Number

  1

• Research summary

  ABP 215 is being developed as a biosimilar to bevacizumab for use as a cancer therapy in both the United States (US) and the European Union (EU). The primary objective of this Phase 1 study is to determine if ABP 215 and bevacizumab (i.e., Food and Drug Administration [FDA]-licensed bevacizumab and EU-authorized bevacizumab) are bioequivalent in healthy male subjects. The safety and tolerability of the ABP 215 will also be assessed and compared to that of bevacizumab by treatment group. This application is for the EU arm of the global study, which will use the EU Reference Medicinal Product (RMP), bevacizumab.

• REC name

  Wales REC 1

• REC reference

  12/WA/0140

• Date of REC Opinion

  16 May 2012

• REC opinion

  Further Information Favourable Opinion