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Trial record 3 of 4 for:    SB4
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Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects

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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Biological: SB4 Biological: EU sourced Enbrel Biological: US sourced Enbrel Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: 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
Study Start Date : May 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Arms and Interventions
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Arm Intervention/treatment
Experimental: SB4 and EU sourced Enbrel in Part A
SB4 followed by EU sourced Enbrel
 Biological: SB4
SC administration

Biological: EU sourced Enbrel
SC administration
Experimental: EU sourced Enbrel and SB4 in Part A
EU sourced Enbrel followed by SB4
 Biological: SB4
SC administration

Biological: EU sourced Enbrel
SC administration
Experimental: SB4 and US sourced Enbrel in Part B
SB4 followed by US sourced Enbrel
 Biological: SB4
SC administration

Biological: US sourced Enbrel
SC administration
Experimental: US sourced Enbrel and SB4 in Part B
US sourced Enbrel followed by SB4
 Biological: SB4
SC administration

Biological: US sourced Enbrel
SC administration
EU and US sourced Enbrel in Part C
EU sourced Enbrel followed by US sourced Enbrel
 Biological: EU sourced Enbrel
SC administration

Biological: US sourced Enbrel
SC administration
US and EU sourced Enbrel in Part C
US sourced Enbrel followed by EU sourced Enbrel
 Biological: EU sourced Enbrel
SC administration

Biological: US sourced Enbrel
SC administration


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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


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

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.
Contacts and Locations
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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): NCT01865552


Locations
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Germany
Parexel International GmbH
Berlin, Germany
Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
Investigators
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Principal Investigator: Rainard Fuhr, M.D., Ph.D. Parexel
More Information
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Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT01865552    
Other Study ID Numbers: SB4-G11-NHV
2012-004371-39 ( EudraCT Number )
First Posted: May 31, 2013    Key Record Dates
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019
Last Verified: June 2019
Keywords provided by Samsung Bioepis Co., Ltd.:
Pharmacokinetics
Additional relevant MeSH terms:
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Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors