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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Etanercept Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : March 24, 2017
Actual Primary Completion Date : August 7, 2017
Actual Study Completion Date : August 7, 2017

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: Sequence 1
SB4 (etanercept) 50 mg/mL PFS and AI
 Drug: Etanercept
50 mg/mL PFS and AI
Experimental: Sequence 2
SB4 (etanercept) 50 mg/mL AI and PFS
 Drug: Etanercept
50 mg/mL PFS and AI


Outcome Measures
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Primary Outcome Measures :
  1. AUCinf ACUinf [ Time Frame: 56 days ]
    Area under the concentration-time curve from time zero to infinity

  2. AUClast [ Time Frame: 56 days ]
    Area under the concentration-time curve from time zero to the last quantifiable concentration

  3. Cmax [ Time Frame: 56 days ]
    Maximum serum concentration


Eligibility Criteria
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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:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
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): NCT03193203


Locations
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Netherlands
PRA Health Sciences
Groningen, Netherlands
Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
More Information
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Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT03193203    
Other Study ID Numbers: SB4-G12-NHV
2016-004993-16 ( EudraCT Number )
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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