To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin

Study Overview
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Brief Summary
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This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product CT-P16 with EU-approved Avastin and US-licensed Avastin after a single IV infusion of 5mg/kg of each product to healthy male subjects

Detailed Description
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This study is a double-blind, three-arm, parallel group, single-dose study. A total of 141 subjects will be enrolled; 47 subjects in each of the 3 arms of the clinical study. In each arm, all subjects will receive a single dose (5 mg/kg) of either CT-P16, EU-approved Avastin, or US-licensed Avastin by intravenous (IV) infusion for 90 min (±5 min) on Day 1 followed by 15 weeks during which the PK, safety, and immunogenicity measurements will be made. The randomization will be stratified by body weight and site.

Official Title
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A Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Bevacizumab (CT-P16, EU-approved Avastin and US-licensed Avastin) in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: CT-P16
* Drug: EU-approved Avastin
* Drug: US-licensed Avastin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects between the ages of 19 and 55 years, both inclusive Body Mass Index (BMI) between 18.0 and 29.9 kg/m2 (both inclusive) and a body weight ≥ 50 kg Exclusion Criteria: Subject is a female. Clinically significant allergic reactions, hypersensitivity A disease classed as significant by the Investigator Non-healing wound, ulcer, bone fracture, a major surgical procedure, significant traumatic injury Any malignancy Undergone treatment with an investigational drug or participated in another clinical trial Plans to father a child or donates sperms

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-P16<br>CT-P16 will be administrated once in IV infusion of 5mg/KG to healthy male subjects | Drug: CT-P16<br>* CT-P16 is a biosimilar product for Avastin<br>* Other names: bevacizumab;|
| Active Comparator: EU-approved Avastin<br>EU-approved Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects | Drug: EU-approved Avastin<br>* EU-approved Avastin<br>* Other names: bevacizumab;|
| Active Comparator: US-licensed Avastin<br>US-licensed Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects | Drug: US-licensed Avastin<br>* US-licensed Avastin<br>* Other names: bevacizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-inf | Area under the concentration-time curve from time zero to infinity | pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI | 
| Cmax | Maximum Serum Concentration (Cmax) | pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI | 
| AUC0-last | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration | pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional Pharmacokinetics (Time to Cmax) | To assess the additional PK of study drugs (Time to Cmax) | pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI | 
| Number of Participants With Anti-Drug Antibody Positive | number of participants with anti-drug antibody positive at post-dose | up to 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, Pharmacokinetics, Immunogenicity