A Randomised, Double Blind, Two-Arm, Single Dose, Parallel Phase I Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (a proposed bevacizumab biosimilar drug) and EU-approved Avastin in Japanese Healthy Male Volunteers

INTERVENTION: Intervention name : MB02 INN of the intervention : ‐ Dosage And administration of the intervention : 3 mg/kg, administered as a 90 minute IV infusion Control intervention name : Bevacizuma INN of the control intervention : Bevacizuma Dosage And administration of the control intervention : 3 mg/kg, administered as a 90 minute IV infusion CONDITION: ‐ PRIMARY OUTCOME: bioequivalence; To demonstrate pharmacokinetic similarity, as primary assessed by the Area Under the Concentration‐time curve extrapolated to infinity (AUC(0‐inf)) between the two study arms, MB02 and EU‐Avastin SECONDARY OUTCOME: safety, pharmacokinetics, other; ‐ Evaluation and comparison of derived PK parameters not covered by the primary endpoints for MB02 and EU approved Avastin; ‐ To compare the safety profile of MB02 and EU approved Avastin; ‐ To compare the immunogenicity of MB02 and EU approved Avastin INCLUSION CRITERIA: 1) Subjects with Body mass index (BMI) between =>18.5 to =<28 kg/m2 and total body weight between =>50 and =<100 kg, at Screening 2) Systolic blood pressure =<140 mm Hg and diastolic blood pressure =<90 mm H g. 3) Computerized (12‐lead) ECG recording without signs of clinically relevant pathology. 4) All other values for hematology, coagulation and for biochemistry and urinalysis tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Investigator, according to the laboratory values from study value. 5) Ability and willingness of accordance with limitation rules in the study period.