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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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SB2

SB2 (Study drug)

Group Type EXPERIMENTAL

SB2

Intervention Type BIOLOGICAL

IV infusion

EU Remicade

EU sourced Remicade (Reference drug)

Group Type ACTIVE_COMPARATOR

EU Remicade

Intervention Type BIOLOGICAL

IV infusion

US Remicade

US sourced Remicade (Reference drug)

Group Type ACTIVE_COMPARATOR

US Remicade

Intervention Type BIOLOGICAL

IV infusion

Interventions

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SB2

IV infusion

Intervention Type BIOLOGICAL

EU Remicade

IV infusion

Intervention Type BIOLOGICAL

US Remicade

IV infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes