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History of Changes for Study: NCT03193203
Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects
Latest version (submitted September 26, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 19, 2017 None (earliest Version on record)
2 July 10, 2017 Study Status
3 August 31, 2017 Recruitment Status and Study Status
4 September 26, 2017 Study Status
Comparison Format:

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Study NCT03193203
Submitted Date:  June 19, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: SB4-G12-NHV
Brief Title: Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects
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
Secondary IDs: 2016-004993-16 [EudraCT Number]
Open or close this module Study Status
Record Verification: June 2017
Overall Status: Active, not recruiting
Study Start: April 17, 2017
Primary Completion: August 2017 [Anticipated]
Study Completion: August 2017 [Anticipated]
First Submitted: June 19, 2017
First Submitted that
Met QC Criteria:
June 19, 2017
First Posted: June 20, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
June 19, 2017
Last Update Posted: June 20, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Samsung Bioepis Co., Ltd.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Healthy
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Phase 1
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 50 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 55 Years
Sex: Male
Gender Based:
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
Open or close this module Contacts/Locations
Locations: Netherlands
PRA Health Sciences
Groningen, Netherlands
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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