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Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects

NCT01865552 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2019-06-04

Study results available
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Summary

The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.

Conditions

  • Healthy

Interventions

BIOLOGICAL

SB4

SC administration

BIOLOGICAL

EU sourced Enbrel

SC administration

BIOLOGICAL

US sourced Enbrel

SC administration

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
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-08-31
Completion
2013-08-31

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 NCT01865552 on ClinicalTrials.gov