Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects

A Randomised, Open-labelled, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, and Tolerability of the Pre-filled Pen and PFS of SB5 in Healthy Subjects

The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the pre-filled pen and pre-filled syringe of SB5 in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: Pen of SB5; Biological: PFS of SB5

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
    • Samsung Investigational Site
• New Zealand
  • Auckland, New Zealand
    • 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 to 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 subject's last 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
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pen of SB5; Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)	Biological: Pen of SB5
Active Comparator: PFS of SB5; PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)	Biological: PFS of SB5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)	0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)	0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
Maximum Serum Concentration (Cmax)	0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to Reach Cmax (Tmax)	0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose

Collaborators and Investigators

• Sponsor: Samsung Bioepis Co., Ltd.

Publications and helpful links

General Publications

• Shin D, Lee Y, Jeong D, Ellis-Pegler R. Comparative pharmacokinetics of an adalimumab biosimilar SB5 administered via autoinjector or prefilled syringe in healthy subjects. Drug Des Devel Ther. 2018 Nov 5;12:3799-3805. doi: 10.2147/DDDT.S169082. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: December 22, 2014
• First Submitted That Met QC Criteria: December 26, 2014
• First Posted (Estimate): December 29, 2014

Study Record Updates

• Last Update Posted (Actual): March 18, 2019
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: SB5-G12-NHV; 2014-005178-12 (EudraCT Number)