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
Phase: PHASE1
Conditions: Healthy Volunteers, Male, Japanese
Sponsor: mAbxience Research S.L.

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TABLE OF CONTENTS 
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INTRODUCTION 
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Overview 
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Summary of Nonclinical Experience 
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Summary of Clinical Experience 
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OBJECTIVES 
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Primary Objective 
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Primary Endpoints 
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INVESTIGATIONAL PLAN 
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Study Design 
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Discussion of Study Design 
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SELECTION OF STUDY POPULATION 
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Inclusion Criteria 
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STUDY TREATMENTS 
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Study Treatment Compliance 
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Drug Accountability 
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CONCOMITANT THERAPIES AND OTHER RESTRICTIONS 
7.1
Concomitant Medications 
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Diet 
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Smoking 
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Exercise 
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Blood Donation 
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Contraception 
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STUDY ASSESSMENTS AND PROCEDURES 
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8.1
Pharmacokinetic Assessments 
8.1.1
Pharmacokinetic Blood Sample Collection and Processing 
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Analytical Methodology 
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Immunogenicity Assessments 
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Immunogenicity Blood Sample Collection and Processing 
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Analytical Methodology 
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Safety and Tolerability Assessments 
8.3.1
Adverse Events 
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8.3.2
Clinical Laboratory Evaluations 
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8.3.3
Vital Signs 
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8.3.4
12-Lead Electrocardiogram 
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8.3.5
Physical Examination 
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SAMPLE SIZE AND DATA ANALYSES 
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9.1
Determination of Sample Size 
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9.2
Analysis Populations 
9.2.1
Pharmacokinetic Population 
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9.2.2
Safety Population 
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9.3
Pharmacokinetic Analyses 
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9.4
Safety Analysis 
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9.4.1
Medical Safety Monitoring 
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9.5
Interim Analysis 
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10
QUALITY CONTROL AND QUALITY ASSURANCE 
10.1
Auditing and Inspection 
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10.2
Monitoring 
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11
DATA HANDLING AND RECORD KEEPING 
11.1
Data Handling 
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11.2
Case Report Form 
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11.3
Records 
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12
ETHICAL AND REGULATORY CONSIDERATIONS 
12.1
Institutional Review Board 
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12.2
Regulatory Considerations 
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REFERENCES 
 0%–,QYHVWLJator’s Brochure. (Version -XO\
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APPENDICES 

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Appendix 1: Schedule of Assessments 

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