Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-09-30

Brief Summary

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The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) 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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SB5

SB5, single dose of 40 mg via subcutaneous injection (study drug)

Group Type EXPERIMENTAL

SB5

Intervention Type BIOLOGICAL

EU sourced Humira®

Intervention Type BIOLOGICAL

EU sourced Humira®

EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

Group Type ACTIVE_COMPARATOR

SB5

Intervention Type BIOLOGICAL

US sourced Humira®

Intervention Type BIOLOGICAL

US sourced Humira®

US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

Group Type ACTIVE_COMPARATOR

EU sourced Humira®

Intervention Type BIOLOGICAL

US sourced Humira®

Intervention Type BIOLOGICAL

Interventions

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SB5

Intervention Type BIOLOGICAL

EU sourced Humira®

Intervention Type BIOLOGICAL

US sourced Humira®

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects
* Have 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 investigational product 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 4 weeks 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 4 weeks or 10 half-lives of the medication prior to investigational product administration

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes