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OpenTrials
Completed

NCT Number: NCT01922336

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International GmbH

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB2

Biological

IV infusion

EU Remicade

Biological

IV infusion

US Remicade

Biological

IV infusion

Primary outcomes

  1. Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)

    Time frame: 71 days

  2. Maximum Serum Concentration (Cmax)

    Time frame: 71 days

  3. Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)

    Time frame: 71 days

Secondary outcomes

  1. Time to Cmax (Tmax)

    Time frame: 71 days

Sponsors and collaborators

Lead sponsor

Samsung Bioepis Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 14, 2013
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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