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Trial record 3 of 4 for:    SB4

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male 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: NCT01865552
Recruitment Status : Completed
First Posted : May 31, 2013
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Tracking Information
First Submitted Date  ICMJE May 27, 2013
First Posted Date  ICMJE May 31, 2013
Results First Submitted Date  ICMJE October 8, 2018
Results First Posted Date  ICMJE June 4, 2019
Last Update Posted Date June 4, 2019
Study Start Date  ICMJE May 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2019)
  • Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) [ Time Frame: 0 to 480 hours post-dose ]
    pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
  • Maximum Serum Concentration (Cmax) [ Time Frame: 0 to 480 hours post-dose ]
    pre-dose (0 h) and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose.
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
  • Area under the concentration-time curve from time zero to infinity (AUCinf) [ Time Frame: 21 days ]
  • Maximum serum concentration (Cmax) [ Time Frame: 21 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2019)
  • Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) [ Time Frame: 0 to 480 hours post-dose ]
    pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
  • Time to Cmax (Tmax) [ Time Frame: 0 to 480 hours post-dose ]
    pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
  • Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast) [ Time Frame: 21 days ]
  • Time to Cmax (Tmax) [ Time Frame: 21 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 SB4 in Healthy Male Subjects
Official Title  ICMJE A Randomised, Single-blind, Three-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Etanercept (SB4, EU Sourced Enbrel® and US Sourced Enbrel®) in Healthy Male Subjects
Brief Summary The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.
Detailed Description
  • Part A: Comparison between SB4 and EU sourced Enbrel
  • Part B: Comparison between SB4 and US sourced Enbrel
  • Part C: Comparison between EU sourced Enbrel and US sourced Enbrel
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: SB4
    SC administration
  • Biological: EU sourced Enbrel
    SC administration
  • Biological: US sourced Enbrel
    SC administration
Study Arms  ICMJE
  • Experimental: SB4 and EU sourced Enbrel in Part A
    SB4 followed by EU sourced Enbrel
    Interventions:
    • Biological: SB4
    • Biological: EU sourced Enbrel
  • Experimental: EU sourced Enbrel and SB4 in Part A
    EU sourced Enbrel followed by SB4
    Interventions:
    • Biological: SB4
    • Biological: EU sourced Enbrel
  • Experimental: SB4 and US sourced Enbrel in Part B
    SB4 followed by US sourced Enbrel
    Interventions:
    • Biological: SB4
    • Biological: US sourced Enbrel
  • Experimental: US sourced Enbrel and SB4 in Part B
    US sourced Enbrel followed by SB4
    Interventions:
    • Biological: SB4
    • Biological: US sourced Enbrel
  • EU and US sourced Enbrel in Part C
    EU sourced Enbrel followed by US sourced Enbrel
    Interventions:
    • Biological: EU sourced Enbrel
    • Biological: US sourced Enbrel
  • US and EU sourced Enbrel in Part C
    US sourced Enbrel followed by EU sourced Enbrel
    Interventions:
    • Biological: EU sourced Enbrel
    • Biological: US sourced Enbrel
Publications * Not Provided

*   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 30, 2013)
138
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects
  • Have a body weight between 60 and 94.9 kg and 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 IP formulation or comparable drugs.
  • active or latent Tuberculosis or who have a history of TB.
  • 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 30 days 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 1 month or 10 half-lives of the medication prior to the first administration of IP.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
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 NCT01865552
Other Study ID Numbers  ICMJE SB4-G11-NHV
2012-004371-39 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Samsung Bioepis Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Samsung Bioepis Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rainard Fuhr, M.D., Ph.D. Parexel
PRS Account Samsung Bioepis Co., Ltd.
Verification Date June 2019

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