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Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01922336
Recruitment Status : Completed
First Posted : August 14, 2013
Results First Posted : February 21, 2019
Last Update Posted : February 21, 2019
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 SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Biological: SB2 Biological: EU Remicade Biological: US Remicade Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 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 Infliximab (SB2, EU Sourced Remicade® and US Sourced Remicade®) in Healthy Subjects
Study Start Date : July 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: SB2
SB2 (Study drug)
Biological: SB2
IV infusion

Active Comparator: EU Remicade
EU sourced Remicade (Reference drug)
Biological: EU Remicade
IV infusion

Active Comparator: US Remicade
US sourced Remicade (Reference drug)
Biological: US Remicade
IV infusion




Primary Outcome Measures :
  1. Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) [ Time Frame: 71 days ]
  2. Maximum Serum Concentration (Cmax) [ Time Frame: 71 days ]
  3. Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) [ Time Frame: 71 days ]

Secondary Outcome Measures :
  1. Time to Cmax (Tmax) [ Time Frame: 71 days ]


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 female subjects of non-childbearing potential and healthy male subjects
  • Have a body weight between 60.0 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 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 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 administration of investigational product.

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): NCT01922336


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT01922336     History of Changes
Other Study ID Numbers: SB2-G11-NHV
2012-005306-22 ( EudraCT Number )
First Posted: August 14, 2013    Key Record Dates
Results First Posted: February 21, 2019
Last Update Posted: February 21, 2019
Last Verified: October 2018

Keywords provided by Samsung Bioepis Co., Ltd.:
Pharmacokinetics

Additional relevant MeSH terms:
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Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents