Overview
Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects
Status:
Completed
Completed
Trial end date:
2017-08-07
2017-08-07
Target enrollment:
0
0
Participant gender:
Male
Male
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Samsung Bioepis Co., Ltd.Treatments:
Etanercept
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