A study assessing the similarity of Avastin (Registered Trademark) and the trial drug BAT1706.

Interventions: Three Bevacizumab Preperations
Arm 1:BAT1706
100 mg in 4 mL - 1mg/kg
Recombinant humanised monoclonal antibody - bevacizumab
1 time only Intravenous infusion.
Arm 2: Avastin (Registered Trademark) United States-licenced (bevacizumab)
100 mg in 4 mL- 1mg/kg
Recombinant humanised monoclonal antibody - bevacizumab
1 time only Intravenous infusion.
Arm 3: Avastin (Registered Trademark) European Approved (bevacizumab)
100 mg in 4 mL- 1mg/kg
Recombinant humanised monoclonal antibody - bevacizumab
1 time only Intravenous infusion.
As the Infusion will be administered while the participants are inpatients of the facility, no strategy for adherence is required.
Primary outcome(s): To establish pairwise pharmacokinetic (PK) similarity between BAT1706, EU Avastin and US-Avastin after a single intravenous (IV) infusion in healthy male subjects.
The primary PK parameters will consist of:
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf).[Blood samples for analysis of serum concentrations of the study drugs will be collected at the following specified times to perform a comparison of PK similarity.
Pre infusion - 0 hour or within 1 hour prior to the start of the infusion.
Mid infusion - at 45 minutes - relative to the start of infusion.
End of infusion - 1 hour, 2 hours, 5 hours, 8 hours, 12 hours from the end of infusion, and 24 hours (Day 2), 48 hours (Day 3), 96 hours (day 5), 168 hours (day 8), 240 hours (Day 11), 336 hours (Day 15), 504 hours (day 22), 672 hours (Day 29), 840 hours (Day 36), 1008 hours (Day 43), 1344 hours (Day 57), 1680 hours (Day 71), 2016 hours (Day85) and 2352 hours (Day 99) post start of infusion.
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Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Pharmacokinetics