A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Infliximab (SB2, EU Sourced Remicade® and US Sourced Remicade®) in Healthy Subjects

Samsung Bioepis Co., Ltd.1 site in 1 country159 target enrollmentJuly 2013

ConditionsHealthy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: Samsung Bioepis Co., Ltd.
Enrollment: 159
Locations: 1
Primary Endpoint: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

October 2013

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Samsung Bioepis Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy female subjects of non-childbearing potential and healthy male subjects
•Have a body weight between 60.0 and 94.9 kg and a body mass index between 20.0 and 29.9 kg/m², inclusive.

Exclusion Criteria

•history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference IP formulation or comparable drugs.
•active or latent Tuberculosis or who have a history of Tuberculosis.
•history of invasive systemic fungal infections or other opportunistic infections
•systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
•serious infection associated with hospitalisation and/or which required intravenous antibiotics
•history of and/or current cardiac disease
•have received live vaccine(s) within 30 days prior to Screening or who will require live vaccine(s) between Screening and the final study visit.
•Intake medication with a half-life \> 24 h within 1 month or 10 half-lives of the medication prior to the administration of investigational product.