Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects

A Randomised, Single-blind, Three-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Etanercept (SB4, EU Sourced Enbrel® and US Sourced Enbrel®) in Healthy Male Subjects

The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.

• Part A: Comparison between SB4 and EU sourced Enbrel
• Part B: Comparison between SB4 and US sourced Enbrel
• Part C: Comparison between EU sourced Enbrel and US sourced Enbrel

Inclusion Criteria:

• Healthy male subjects
• Have a body weight between 60 and 94.9 kg and a body mass index between 20.0 and 29.9 kg/m², inclusive.

Exclusion Criteria:

• history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference IP formulation or comparable drugs.
• active or latent Tuberculosis or who have a history of TB.
• history of invasive systemic fungal infections or other opportunistic infections
• systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
• serious infection associated with hospitalisation and/or which required intravenous antibiotics
• history of and/or current cardiac disease
• have received live vaccine(s) within 30 days prior to Screening or who will require live vaccine(s) between Screening and the final study visit.
• Intake medication with a half-life > 24 h within 1 month or 10 half-lives of the medication prior to the first administration of IP.