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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005332-15 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB5 | Experimental | SB5, single dose of 40 mg via subcutaneous injection (study drug) |
|
| EU sourced Humira® | Active Comparator | EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug) |
|
| US sourced Humira® | Active Comparator | US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB5 | Biological |
| ||
| EU sourced Humira® |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Investigational Site | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33263165 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SB5 (Proposed Adalimumab Biosimilar) | SB5, single dose of 40 mg via subcutaneous injection (study drug) SB5 EU sourced Humira® |
| FG001 | EU Sourced Humira® | EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug) SB5 US sourced Humira® |
| FG002 | US Sourced Humira® | US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug) EU sourced Humira® US sourced Humira® |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SB5 (Proposed Adalimumab Biosimilar) | SB5, single dose of 40 mg via subcutaneous injection (study drug) SB5 EU sourced Humira® |
| BG001 | EU Sourced Humira® | EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug) SB5 US sourced Humira® |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics. | Posted | Mean | Standard Deviation | μg·h/mL | 0 to 1680 hours post-dose |
|
The PK, safety, tolerability, and immunogenicity assessments were performed for maximum 10 weeks after single-dose administration of SB5, EU sourced Humira®, or US sourced Humira®.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SB5 (Proposed Adalimumab Biosimilar) | SB5, single dose of 40 mg via subcutaneous injection (study drug) SB5 EU sourced Humira® |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samsung Bioepis | Samsung Bioepis | +82 31 8061 4534 | sbregistry@samsung.com |
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| Biological |
|
| US sourced Humira® | Biological |
|
| BG002 | US Sourced Humira® | US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug) EU sourced Humira® US sourced Humira® |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | US Sourced Humira® | US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug) EU sourced Humira® US sourced Humira® |
|
|
| Primary | 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 | Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics. | Posted | Mean | Standard Deviation | μg/mL | 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 |
|
|
|
| Primary | 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 | Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics. | Posted | Mean | Standard Deviation | μg·h/mL | 0 to 1680 hours post-dose |
|
|
|
| Secondary | 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 | Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics. | Posted | Mean | Standard Deviation | h | 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 |
|
|
|
| 1 |
| 63 |
| 29 |
| 63 |
| EG001 | EU Sourced Humira® | EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug) SB5 US sourced Humira® | 0 | 63 | 17 | 63 |
| EG002 | US Sourced Humira® | US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug) EU sourced Humira® US sourced Humira® | 1 | 63 | 25 | 63 |
| Psychotic disorder | Psychiatric disorders | Systematic Assessment |
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| Oral herpes | Infections and infestations | Systematic Assessment |
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| Rhinitis | Infections and infestations | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
|
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