Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers

Inclusion Criteria

• Males of any race, between 18 and 55 years of age, inclusive, at Screening.
• Body mass index between 18.5 and 29.9 kg/m2, inclusive, at Screening and Check-in.
• Total body weight between 60 and 95 kg, inclusive, at Screening and Check-in.
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhaemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is acceptable) at Screening or Check-in as assessed by the Investigator (or designee).
• Relevant clinical laboratory evaluations of haematology, coagulation, urinalysis and clinical chemistry within the following ranges at Screening and Check in. A single repeat test will be allowed at each timepoint.
• Absolute neutrophil count ≥1.5 × 109 L
• Platelet count ≥100 × 109 L
• Haemoglobin >10 g/dl
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ ULN
• Alkaline phosphatase (ALP) ≤1.5 × ULN
• Total bilirubin ≤ 1.5 ULN with direct bilirubin ULN
• Blood urea nitrogen ≤1.5 × ULN
• Creatinine 24 units per week. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
• Positive hepatitis panel, positive human immunodeficiency test. Subjects whose results are compatible with prior immunisation and not infection may be included at the discretion of the Investigator.
• Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to Check-in, or within 5 half lives of the investigational drug used in the study.
• Use or intend to use slow-release medications/products considered to still be active within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
• Use or intend use of any prescription medications/ nonprescription products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator or designee.
• Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
• Have received a live or attenuated vaccine from 3 months prior to Screening or have the intention to receive a vaccine during the study.
• Intend to travel to a region where a vaccination will be required due to endemic disease within 3 months of dosing.
• Previous treatment with an anti VEGF antibody or any other protein or antibody targeting the VEGF receptor.
• Use of tobacco- or nicotine-containing products within 1 year prior to Check-in, or positive cotinine test upon Screening or Check-in.
• Receipt of blood products within 60 days prior to Check-in.
• Donation of blood from 90 days prior to Screening, plasma from 14 days prior to Screening, or platelets from 42 days prior to Screening.
• Poor peripheral venous access.
• History of abnormal peripheral sensation including paraesthesia and/or numbness in arms and/or legs.
• Have previously completed or withdrawn from this study or any other study investigating bevacizumab, and/or have previously received bevacizumab.
• Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
• Vulnerable subjects (e.g. persons kept in detention).
• Subjects who are study site employees or immediate family members of a study site or Mabxience employee.