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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005178-12 | EudraCT Number |
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The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the pre-filled pen and pre-filled syringe of SB5 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pen of SB5 | Experimental | Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug) |
|
| PFS of SB5 | Active Comparator | PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pen of SB5 | Biological |
| ||
| PFS of SB5 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) | 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose | |
| Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose | |
| Maximum Serum Concentration (Cmax) | 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Cmax (Tmax) | 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Investigational Site | Antwerp | Belgium | ||||
| Samsung Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30464411 | Derived | Shin D, Lee Y, Jeong D, Ellis-Pegler R. Comparative pharmacokinetics of an adalimumab biosimilar SB5 administered via autoinjector or prefilled syringe in healthy subjects. Drug Des Devel Ther. 2018 Nov 5;12:3799-3805. doi: 10.2147/DDDT.S169082. eCollection 2018. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pen of SB5 | Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug) Pen of SB5 |
| FG001 | PFS of SB5 | PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug) PFS of SB5 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pen of SB5 | Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug) Pen of SB5 |
| BG001 | PFS of SB5 | PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug) PFS of SB5 |
| 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) | Posted | Mean | Standard Deviation | h·μg/mL | 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose |
|
|
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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 | Pen of SB5 | Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug) Pen of SB5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clavicle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Samsung Bioepis Co., Ltd. | sbregistry@samsung.com |
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|
| Auckland |
| New Zealand |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
| Participants |
|
|
| Primary | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | Posted | Mean | Standard Deviation | h·μg/mL | 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose |
|
|
|
| Primary | Maximum Serum Concentration (Cmax) | Posted | Mean | Standard Deviation | μg/mL | 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose |
|
|
|
| Secondary | Time to Reach Cmax (Tmax) | Posted | Median | Full Range | h | 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose |
|
|
|
| 1 |
| 95 |
| 39 |
| 95 |
| EG001 | PFS of SB5 | PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug) PFS of SB5 | 2 | 94 | 28 | 94 |
| Hand fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
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