Healthy
Conditions
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.
Interventions
DRUGEtanercept
50 mg/mL PFS and AI
Sponsors
Samsung Bioepis Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf ACUinf | 56 days | Area under the concentration-time curve from time zero to infinity |
| AUClast | 56 days | Area under the concentration-time curve from time zero to the last quantifiable concentration |
| Cmax | 56 days | Maximum serum concentration |
Countries
Netherlands
Outcome results
None listed