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

A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Adalimumab (SB5, EU Sourced Humira® and US Sourced Humira®) in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: SB5; Biological: EU sourced Humira®; Biological: US sourced Humira®

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Samsung Investigational Site

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SB5; SB5, single dose of 40 mg via subcutaneous injection (study drug)	Biological: SB5; Biological: EU sourced Humira®
Active Comparator: EU sourced Humira®; EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)	Biological: SB5; Biological: US sourced Humira®
Active Comparator: US sourced Humira®; US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)	Biological: EU sourced Humira®; Biological: US sourced Humira®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)	pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose	0 to 1680 hours post-dose
Maximum Serum Concentration (Cmax)	pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose	pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)	pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose	0 to 1680 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Cmax (Tmax)	pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose	pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose

Collaborators and Investigators

• Sponsor: Samsung Bioepis Co., Ltd.

Publications and helpful links

General Publications

• Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: May 20, 2014
• First Submitted That Met QC Criteria: May 20, 2014
• First Posted (Estimate): May 22, 2014

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: SB5-G11-NHV; 2013-005332-15 (EudraCT Number)