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

Samsung

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: US sourced Humira®; Biological: EU sourced Humira®; Biological: SB5

Study type: Interventional

Funder types: Industry

Identifiers

NCT02144714

2013-005332-15 (EudraCT Number)

SB5-G11-NHV

Details and patient eligibility

About

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.

Enrollment: 189 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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189 participants in 3 patient groups

SB5

Experimental group

Description:

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

Treatment:

Biological: EU sourced Humira®

Biological: SB5

EU sourced Humira®

Active Comparator group

Description:

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

Treatment:

Biological: US sourced Humira®

Biological: SB5

US sourced Humira®

Active Comparator group

Description:

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

Treatment:

Biological: US sourced Humira®

Biological: EU sourced Humira®