Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy subjects.

Official Title
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A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Adalimumab (SB5, EU Sourced Humira® and US Sourced Humira®) in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Biological: SB5
* Biological: EU sourced Humira®
* Biological: US sourced Humira®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects Have 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 investigational product formulation or comparable drugs Active or latent Tuberculosis or who have a history of Tuberculosis 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 4 weeks 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 4 weeks or 10 half-lives of the medication prior to investigational product administration

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

Sexes Eligible for Study
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All

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB5<br>SB5, single dose of 40 mg via subcutaneous injection (study drug) | Biological: SB5<br> <br> Biological: EU sourced Humira®<br> <br> |
| Active Comparator: EU sourced Humira®<br>EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug) | Biological: SB5<br> <br> Biological: US sourced Humira®<br> <br> |
| Active Comparator: US sourced Humira®<br>US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug) | Biological: EU sourced Humira®<br> <br> Biological: US sourced Humira®<br> <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 (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose | 0 to 1680 hours post-dose | 
| Maximum Serum Concentration (Cmax) | pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose | pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose | 
| Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose | 0 to 1680 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Cmax (Tmax) | pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose | pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose |