NCT Number: NCT02326233
Pharmacokinetics, Safety, and Tolerability Study of the 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.
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Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Samsung Investigational Site, Antwerp, Belgium
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
PFS of SB5
BiologicalPrimary outcomes
-
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Time frame: 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)
Time frame: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
-
Maximum Serum Concentration (Cmax)
Time frame: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
Secondary outcomes
-
Time to Reach Cmax (Tmax)
Time frame: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
Sponsors and collaborators
Lead sponsor
Samsung Bioepis Co., Ltd.
Industry
Registry information
Official study 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
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Dec 29, 2014
- Registry last updated
- Mar 18, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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