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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Biological: SB4
* Biological: EU sourced Enbrel
* Biological: US sourced Enbrel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB4 and EU sourced Enbrel in Part A<br>SB4 followed by EU sourced Enbrel | Biological: SB4<br>* SC administration<br>Biological: EU sourced Enbrel<br>* SC administration<br>|
| Experimental: EU sourced Enbrel and SB4 in Part A<br>EU sourced Enbrel followed by SB4 | Biological: SB4<br>* SC administration<br>Biological: EU sourced Enbrel<br>* SC administration<br>|
| Experimental: SB4 and US sourced Enbrel in Part B<br>SB4 followed by US sourced Enbrel | Biological: SB4<br>* SC administration<br>Biological: US sourced Enbrel<br>* SC administration<br>|
| Experimental: US sourced Enbrel and SB4 in Part B<br>US sourced Enbrel followed by SB4 | Biological: SB4<br>* SC administration<br>Biological: US sourced Enbrel<br>* SC administration<br>|
| Other: EU and US sourced Enbrel in Part C<br>EU sourced Enbrel followed by US sourced Enbrel | Biological: EU sourced Enbrel<br>* SC administration<br>Biological: US sourced Enbrel<br>* SC administration<br>|
| Other: US and EU sourced Enbrel in Part C<br>US sourced Enbrel followed by EU sourced Enbrel | Biological: EU sourced Enbrel<br>* SC administration<br>Biological: US sourced Enbrel<br>* SC administration<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics