NCT01865552

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

A Randomised, Single-blind, Three-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Etanercept (SB4, EU Sourced Enbrel® and US Sourced Enbrel®) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Samsung Bioepis Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

* Part A: Comparison between SB4 and EU sourced Enbrel * Part B: Comparison between SB4 and US sourced Enbrel * Part C: Comparison between EU sourced Enbrel and US sourced Enbrel

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	SB4	SC administration
BIOLOGICAL	EU sourced Enbrel	SC administration
BIOLOGICAL	US sourced Enbrel	SC administration

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-05-31
• Last updated: 2019-06-04
• Results posted: 2019-06-04

Locations

1 site across 1 country: Germany