(duplicate) A Phase I study comparing c and Avastin in healthy ma
Research type
Research Study
IRAS ID
136039
Contact name
Annelize Koch
Contact email
Sponsor organisation
PAREXEL
Eudract number
2013-000251-40
ISRCTN Number
n/a
Research summary
The purpose of this study is to find out if the investigational proposed similar biological medicinal product to Avastin (= investigational study drug), is as safe and will result in equivalent blood levels for the drug in the body as Avastin®.
This will be assessed by looking at the pharmacokinetics (the amount of drug in the blood over time) and the side effects of the investigational study drug.
The investigational study drug will be compared to the marketed drug Avastin.
For both the investigational study drug and Avastin, the active ingredient is bevacizumab, which is a humanized monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body against infection and cancer).
Healthy male subjects will be enrolled in this study.
This study will be performed at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Harrow, UK.
Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood samples for pharmacokinetic, immunogenicity and pharmacodynamic analyses will be collected.REC name
London - Riverside Research Ethics Committee
REC reference
13/LO/1075
Date of REC Opinion
5 Sep 2013
REC opinion
Further Information Favourable Opinion