Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers

Double-blind, single-dose, three-treatment, parallel group design PK comparability study of MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution (bevacizumab).

Double-blind, single-dose, three-treatment, parallel group design PK comparability study of MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution (bevacizumab) in a total of 111 healthy, adult male volunteers (37 subjects per treatment arm). After randomization, subjects will receive one of the following treatments: A single 1 mg/kg dose administered by i.v. infusion (25 mL over approximately 90 minutes) of MYL-1402O, an equivalent i.v. infusion of US marketed Avastin® (1 mg/kg), or an equivalent i.v. infusion of EU marketed Avastin® (1 mg/kg).

Eligibility Criteria:
Inclusion Criteria:

* Males aged 18-55 yrs. (inclusive)
* BMI: 19.0 to 30.0 kg/m2 (inclusive)
* Weight: ≥ 60kg and ≤100kg
* Subjects should be willing to use adequate contraception and not donate sperm from admission to clinical research center until 6 months post dosing.
* All intermittent medications should have be stopped at least 14days prior to admission to the clinical research center.
* All intermittent non topical medication must be stopped at least 30days prior to admission to the clinical research center.
* Ability and willingness to abstain from ETOH 48hrs prior to admission to the clinical research center.
* Medical history without significant findings per the PI
* Resting supine systolic BP of ≤140mmHg and diastolic BP of ≤90mmHg
* ECGs (via 12 lead) showing NCS findings per PI
* All clinical laboratory tests of blood and urine, WNL and/or without clinically significant findings
* Willing/able to sign ICF
* Normal bowel habits
* Negative medical history regarding fecal blood positivity
* Normal and/or NCS spot protein/creatinine (PCR) ratio.

Exclusion Criteria:

* Previous participation in the current study
* History of prior exposure to bevacizumab
* Evidence of clinically significant findings
* Cognitive and / or mentally impaired handicaps that would affect ability to make an informed consent and/or remain compliant to the requirements of this trial.
* History of relevant drug and/or food related allergies.
* History of or known hypersensitivity to bevacizumab or other recombinant human or humanized antibodies or inactive ingredients.
* Tobacco product use w/I 1 yr. prior to drug administration.
* History of ETOH and or drug abuse/addiction
* Positive urine drug and ETOH screen for opiates, methadone, cocaine, amphetamines including XTC, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and ETOH.
* Average intake of more than 24 units of ETOH / wk. (1 unit of ETOH equals \~250mL of beer, 100mL of wine or 35mL of spirits).
* Consumption of any foods containing poppy seeds w/I 48 hrs. prior to screening and admission to the clinical research center
* Positive screen for Hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.
* Participation in a drug study w/I 60days or 5 half-lives of the previous drug.
* Participation in more than 3 other drug studies in the 10months prior to drug administration in the current protocol.
* Donation or loss of more than 100mL of blood w/I 60days prior to drug administration. Donation or loss of more than 1.5liters of blood w/I the 10months prior to drug administration.
* Strenuous exercise w/I 96 hrs. Prior to admission to the clinical research center.
* Significant or acute illness w/I 5days prior to drug administration that may impact safety assessments per the judgement of the PI.
* Unsuitable veins for infusion and/or venepuncture
* Surgery including surgery with suturing via a dental procedure or would dehiscence w/I 28days of dosing. Any planned surgery or dental procedures during the study and for at least 30days after follow up.
* Presence of a non-healing wound or fracture.
* History of bleeding disorders
* History of thromboembolic conditions
* History of gastrointestinal perforations or any fistulae.
* History of orthostatic hypotension, fainting spells, blackouts for any reasons.
* History of hypertension
* Medically significant dental disease or dental neglect with signs and or symptoms of local or systemic infection that would likely require a dental procedure during the course of study.