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Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects

NCT02453672 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2019-06-03

Study results available
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Summary

Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab

Conditions

  • Healthy

Interventions

BIOLOGICAL

SB8

SB8, proposed bevacizumab biosimilar

BIOLOGICAL

EU sourced Avastin®

EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)

BIOLOGICAL

US Sourced Avastin®

US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02453672 on ClinicalTrials.gov