Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers

• Status: Unknown status
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mylan Inc.
• Collaborator: Mylan GmbH
• Treatments: Bevacizumab

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.