Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 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 SB2 and Remicade (EU sourced Remicade and US sourced Remicade) 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 Infliximab (SB2, EU Sourced Remicade® and US Sourced Remicade®) in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Biological: SB2
* Biological: EU Remicade
* Biological: US Remicade


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female subjects of non-childbearing potential and healthy male subjects Have a body weight between 60.0 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 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 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 administration of investigational product.

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: SB2<br>SB2 (Study drug) | Biological: SB2<br>* IV infusion<br>|
| Active Comparator: EU Remicade<br>EU sourced Remicade (Reference drug) | Biological: EU Remicade<br>* IV infusion<br>|
| Active Comparator: US Remicade<br>US sourced Remicade (Reference drug) | Biological: US Remicade<br>* IV infusion<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) |  | 71 days | 
| Maximum Serum Concentration (Cmax) |  | 71 days | 
| Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) |  | 71 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Cmax (Tmax) |  | 71 days | 

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