Pharmacokinetics, Safety, and Tolerability Study 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