Clinical trial NCT02326233: Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-12-29
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
timeFrame: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
measure: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
timeFrame: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
measure: Maximum Serum Concentration (Cmax)
timeFrame: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
Secondary outcomes:
measure: Time to Reach Cmax (Tmax)
timeFrame: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Samsung Investigational Site
city: Auckland
country: New Zealand
facility: Samsung Investigational Site
Study officials:
References:
citation: 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.