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

Phase 1

Completed

Brief Summary: 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.

Detailed Description: * 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

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)	0 to 480 hours post-dose	pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Maximum Serum Concentration (Cmax)	0 to 480 hours post-dose	pre-dose (0 h) and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose.

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)	0 to 480 hours post-dose	pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Time to Cmax (Tmax)	0 to 480 hours post-dose	pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose