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Completed

NCT Number: NCT02144714

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 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.

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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

Berlin, Germany

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 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

Treatment and study plan

SB5

Biological

EU sourced Humira®

Biological

US sourced Humira®

Biological

Primary outcomes

  1. Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)

    Time frame: 0 to 1680 hours 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

  2. Maximum Serum Concentration (Cmax)

    Time frame: 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

  3. Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)

    Time frame: 0 to 1680 hours 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

Secondary outcomes

  1. Time to Cmax (Tmax)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Samsung Bioepis Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 22, 2014
Registry last updated
Nov 14, 2018

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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