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Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe 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: NCT03193203
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 19, 2017
First Posted Date  ICMJE June 20, 2017
Last Update Posted Date September 28, 2017
Actual Study Start Date  ICMJE March 24, 2017
Actual Primary Completion Date August 7, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
  • AUCinf ACUinf [ Time Frame: 56 days ]
    Area under the concentration-time curve from time zero to infinity
  • AUClast [ Time Frame: 56 days ]
    Area under the concentration-time curve from time zero to the last quantifiable concentration
  • Cmax [ Time Frame: 56 days ]
    Maximum serum concentration
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects
Official Title  ICMJE A Randomised, Open-label, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, and Tolerability of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects
Brief Summary The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the autoinjector and pre-filled syringe of SB4 in healthy male subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Etanercept
50 mg/mL PFS and AI
Study Arms  ICMJE
  • Experimental: Sequence 1
    SB4 (etanercept) 50 mg/mL PFS and AI
    Intervention: Drug: Etanercept
  • Experimental: Sequence 2
    SB4 (etanercept) 50 mg/mL AI and PFS
    Intervention: Drug: Etanercept
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: June 19, 2017)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 7, 2017
Actual Primary Completion Date August 7, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects aged 18-55 years
  • Have a body weight between 60.0 - 85.5 kg (inclusive) and a body mass index between 20.0 - 28.0 kg/m2 (inclusive)

Exclusion Criteria:

  • Have a history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to etanercept or to any of the excipient
  • Have either active or latent TB or who have a history of TB
  • Have clinically significant active infection within 4 weeks before the first IP administration
  • Have had a history of serious infection
  • Have previously been exposed to etanercept, if known
  • Have previously been exposed to a biological agent or immunosuppressive agent within 120 days prior to the first IP administration
  • Have a history of invasive systemic fungal infections or other opportunistic infections judged as relevant by the Investigator
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 Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03193203
Other Study ID Numbers  ICMJE SB4-G12-NHV
2016-004993-16 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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 June 2017

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