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

October 11, 2018 updated by: Samsung Bioepis Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Parexel International GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SB2
SB2 (Study drug)
Biological: SB2
IV infusion
Active Comparator: EU Remicade
EU sourced Remicade (Reference drug)
Biological: EU Remicade
IV infusion
Active Comparator: US Remicade
US sourced Remicade (Reference drug)
Biological: US Remicade
IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Time Frame: 71 days
71 days
Maximum Serum Concentration (Cmax)
Time Frame: 71 days
71 days
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Time Frame: 71 days
71 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Cmax (Tmax)
Time Frame: 71 days
71 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Bioepis Co., Ltd.

Investigators

  • Principal Investigator: Rainard Fuhr, M.D., Ph.D., Parexel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

August 12, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (Estimate)

August 14, 2013

Study Record Updates

Last Update Posted (Actual)

February 21, 2019

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB2-G11-NHV
  • 2012-005306-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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