Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects

• Status: Completed
• Trial end date: 2017-08-07
• Target enrollment: 0
• Participant gender: 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 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• 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