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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.

Tracking Information
First Submitted Date  ICMJE May 20, 2014
First Posted Date  ICMJE May 22, 2014
Results First Submitted Date  ICMJE January 11, 2018
Results First Posted Date  ICMJE September 21, 2018
Last Update Posted Date November 14, 2018
Actual Study Start Date  ICMJE May 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
  • Area under the concentration-time curve from time zero to infinity (AUCinf) [ Time Frame: 71 days ]
  • Maximum serum concentration (Cmax) [ Time Frame: 71 days ]
  • Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast) [ Time Frame: 71 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
Time to Cmax (Tmax) [ Time Frame: 71 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: SB5
  • Biological: EU sourced Humira®
  • Biological: US sourced Humira®
Study Arms  ICMJE
  • Experimental: SB5
    SB5, single dose of 40 mg via subcutaneous injection (study drug)
    Interventions:
    • Biological: SB5
    • Biological: EU sourced Humira®
  • Active Comparator: EU sourced Humira®
    EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
    Interventions:
    • Biological: SB5
    • Biological: US sourced Humira®
  • Active Comparator: US sourced Humira®
    US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
    Interventions:
    • Biological: EU sourced Humira®
    • Biological: US sourced Humira®
Publications * Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2014)
189
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02144714
Other Study ID Numbers  ICMJE SB5-G11-NHV
2013-005332-15 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samsung Bioepis Co., Ltd.
Study Sponsor  ICMJE Samsung Bioepis Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Samsung Bioepis Co., Ltd.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP