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Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects

NCT01922336 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2019-02-21

Study results available
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Summary

The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy subjects.

Conditions

  • Healthy

Interventions

BIOLOGICAL

SB2

IV infusion

BIOLOGICAL

EU Remicade

IV infusion

BIOLOGICAL

US Remicade

IV infusion

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Rainard Fuhr, M.D., Ph.D. · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Germany

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 NCT01922336 on ClinicalTrials.gov