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

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.

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