Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects
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
2 other identifiers
interventional
138
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 27, 2013
CompletedFirst Posted
Study publicly available on registry
May 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
June 4, 2019
CompletedJune 4, 2019
June 1, 2019
3 months
May 27, 2013
October 8, 2018
June 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
0 to 480 hours post-dose
Maximum Serum Concentration (Cmax)
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.
0 to 480 hours post-dose
Secondary Outcomes (2)
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
0 to 480 hours post-dose
Time to Cmax (Tmax)
0 to 480 hours post-dose
Study Arms (6)
SB4 and EU sourced Enbrel in Part A
EXPERIMENTALSB4 followed by EU sourced Enbrel
EU sourced Enbrel and SB4 in Part A
EXPERIMENTALEU sourced Enbrel followed by SB4
SB4 and US sourced Enbrel in Part B
EXPERIMENTALSB4 followed by US sourced Enbrel
US sourced Enbrel and SB4 in Part B
EXPERIMENTALUS sourced Enbrel followed by SB4
EU and US sourced Enbrel in Part C
OTHEREU sourced Enbrel followed by US sourced Enbrel
US and EU sourced Enbrel in Part C
OTHERUS sourced Enbrel followed by EU sourced Enbrel
Interventions
SC administration
SC administration
SC administration
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parexel International GmbH
Berlin, Germany
Results Point of Contact
- Title
- Director of Clinical Development
- Organization
- Samsung Bioepis
Study Officials
- PRINCIPAL INVESTIGATOR
Rainard Fuhr, M.D., Ph.D.
Parexel
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2013
First Posted
May 31, 2013
Study Start
May 1, 2013
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
June 4, 2019
Results First Posted
June 4, 2019
Record last verified: 2019-06