Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects
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
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Mar 2017
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 24, 2017
CompletedFirst Submitted
Initial submission to the registry
June 19, 2017
CompletedFirst Posted
Study publicly available on registry
June 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2017
CompletedSeptember 28, 2017
June 1, 2017
5 months
June 19, 2017
September 26, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
AUCinf ACUinf
Area under the concentration-time curve from time zero to infinity
56 days
AUClast
Area under the concentration-time curve from time zero to the last quantifiable concentration
56 days
Cmax
Maximum serum concentration
56 days
Study Arms (2)
Sequence 1
EXPERIMENTALSB4 (etanercept) 50 mg/mL PFS and AI
Sequence 2
EXPERIMENTALSB4 (etanercept) 50 mg/mL AI and PFS
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PRA Health Sciences
Groningen, Netherlands
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2017
First Posted
June 20, 2017
Study Start
March 24, 2017
Primary Completion
August 7, 2017
Study Completion
August 7, 2017
Last Updated
September 28, 2017
Record last verified: 2017-06