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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000662-21 | EudraCT Number |
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This is a phase I, randomized, double-blind, parallel-group trial to compare Investigation Medicinal Product (IMP) MSB11022, US- Reference Product (RP), and EU- Reference Medicinal Product (RMP) (Humira®) in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSB11022 | Experimental |
| |
| US-licensed Humira | Active Comparator |
| |
| EU-approved Humira | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSB11022 | Drug | Subjects will receive single dose of 40 milligram (mg) MSB11022 as a subcutaneous injection in the lower abdomen on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary: Area Under the Concentration-Time Curve From time Zero Extrapolated to Infinity (AUC [0-inf]) | Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours | |
| Maximum Observed Serum Concentration (Cmax) | Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours | |
| Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC [0-last]) | Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Observed Serum Concentration (Tmax) | Pre-dose 0 hour, post-dose 4, 8 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours | |
| Apparent Volume of Distribution During the Terminal Phase (Vz/F) | Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27285856 | Result | Hyland E, Mant T, Vlachos P, Attkins N, Ullmann M, Roy S, Wagner V. Comparison of the pharmacokinetics, safety, and immunogenicity of MSB11022, a biosimilar of adalimumab, with Humira((R)) in healthy subjects. Br J Clin Pharmacol. 2016 Oct;82(4):983-93. doi: 10.1111/bcp.13039. Epub 2016 Jul 28. | |
| 33263165 | Derived |
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| US-licensed Humira | Drug | Subject will receive single dose of 40 mg US-licensed Humira as a subcutaneous injection in the lower abdomen on Day 1. |
|
| EU-approved Humira | Drug | Subject will receive single dose of 40 mg EU-approved Humira as a subcutaneous injection in the lower abdomen on Day 1. |
|
| Terminal Half-Life (t1/2) | Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours |
| Apparent Total Clearance (CL/F) | Pre-dose 0 hour, post-dose 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 240, 336, 504, 672, 840, 1008, 1344, 1680 hours |
| Number of Subjects With Injection Site Reactions | Baseline up to Day 71 |
| Number of Subjects With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Death | Baseline up to Day 71 |
| Number of Subjects With Anti-drug Antibodies (ADA) for MSB11022 | Day 1 up to Day 71 |
| Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1. |