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Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02144714
Recruitment Status : Completed
First Posted : May 22, 2014
Results First Posted : September 21, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Biological: SB5 Biological: EU sourced Humira® Biological: US sourced Humira® Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official 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
Actual Study Start Date : May 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: SB5
SB5, single dose of 40 mg via subcutaneous injection (study drug)
Biological: SB5
Biological: EU sourced Humira®
Active Comparator: EU sourced Humira®
EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
Biological: SB5
Biological: US sourced Humira®
Active Comparator: US sourced Humira®
US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
Biological: EU sourced Humira®
Biological: US sourced Humira®



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144714


Locations
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Germany
Samsung Investigational Site
Berlin, Germany
Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
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Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT02144714    
Other Study ID Numbers: SB5-G11-NHV
2013-005332-15 ( EudraCT Number )
First Posted: May 22, 2014    Key Record Dates
Results First Posted: September 21, 2018
Last Update Posted: November 14, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents