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Completed

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Investigational Site, Antwerp, Belgium

Loading trial locations.

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

Pen of SB5

Biological

PFS of SB5

Biological

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. 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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