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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004371-39 | EudraCT Number |
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The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB4 and EU sourced Enbrel in Part A | Experimental | SB4 followed by EU sourced Enbrel |
|
| EU sourced Enbrel and SB4 in Part A | Experimental | EU sourced Enbrel followed by SB4 |
|
| SB4 and US sourced Enbrel in Part B | Experimental | SB4 followed by US sourced Enbrel |
|
| US sourced Enbrel and SB4 in Part B | Experimental | US sourced Enbrel followed by SB4 |
|
| EU and US sourced Enbrel in Part C | Other | EU sourced Enbrel followed by US sourced Enbrel |
|
| US and EU sourced Enbrel in Part C |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB4 | Biological | SC administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) | pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose | 0 to 480 hours post-dose |
| Maximum Serum Concentration (Cmax) | pre-dose (0 h) and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose. | 0 to 480 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose | 0 to 480 hours post-dose |
| Time to Cmax (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rainard Fuhr, M.D., Ph.D. | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International GmbH | Berlin | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | SB4 and EU Sourced Enbrel in Part A | SB4 (Period 1) followed by EU sourced Enbrel (Period 2) SB4: SC administration EU sourced Enbrel: SC administration |
| FG001 | EU Sourced Enbrel and SB4 in Part A | EU sourced Enbrel (Period 1) followed by SB4 (Period 2) SB4: SC administration EU sourced Enbrel: SC administration |
| FG002 | SB4 and US Sourced Enbrel in Part B | SB4 (Period 1) followed by US sourced Enbrel (Period 2) SB4: SC administration US sourced Enbrel: SC administration |
| FG003 | US Sourced Enbrel and SB4 in Part B | US sourced Enbrel (Period 1) followed by SB4 (Period 2) SB4: SC administration US sourced Enbrel: SC administration |
| FG004 | EU and US Sourced Enbrel in Part C | EU sourced Enbrel (Period 1) followed by US sourced Enbrel (Period 2) EU sourced Enbrel: SC administration US sourced Enbrel: SC administration |
| FG005 | US and EU Sourced Enbrel in Part C | US sourced Enbrel (Period 1) followed by EU sourced Enbrel (Period 2) EU sourced Enbrel: SC administration US sourced Enbrel: SC administration |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| |||||||||||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SB4 and EU Sourced Enbrel in Part A | SB4 followed by EU sourced Enbrel SB4: SC administration EU sourced Enbrel: SC administration |
| BG001 | EU Sourced Enbrel and SB4 in Part A |
| 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 and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 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 480 hours post-dose |
|
7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
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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 | SB4 in Part A | SB4: SC administration | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Development | Samsung Bioepis | +82 31 8061 4534 | sbregistry@samsung.com |
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US sourced Enbrel followed by EU sourced Enbrel |
|
| EU sourced Enbrel | Biological | SC administration |
|
| US sourced Enbrel | Biological | SC administration |
|
pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
| 0 to 480 hours post-dose |
| Pathological lab |
|
| Other |
|
| COMPLETED |
|
| NOT COMPLETED |
|
EU sourced Enbrel followed by SB4
SB4: SC administration
EU sourced Enbrel: SC administration
| BG002 | SB4 and US Sourced Enbrel in Part B | SB4 followed by US sourced Enbrel SB4: SC administration US sourced Enbrel: SC administration |
| BG003 | US Sourced Enbrel and SB4 in Part B | US sourced Enbrel followed by SB4 SB4: SC administration US sourced Enbrel: SC administration |
| BG004 | EU and US Sourced Enbrel in Part C | EU sourced Enbrel followed by US sourced Enbrel EU sourced Enbrel: SC administration US sourced Enbrel: SC administration |
| BG005 | US and EU Sourced Enbrel in Part C | US sourced Enbrel followed by EU sourced Enbrel EU sourced Enbrel: SC administration US sourced Enbrel: SC administration |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
SB4: SC administration |
| OG003 | US Sourced Enbrel in Part B | US sourced Enbrel: SC administration |
| OG004 | EU Sourced Enbrel in Part C | EU sourced Enbrel: SC administration |
| OG005 | US Sourced Enbrel in Part C | US sourced Enbrel: SC administration |
|
|
| Primary | Maximum Serum Concentration (Cmax) | pre-dose (0 h) and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose. | Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics. | Posted | Mean | Standard Deviation | μg/mL | 0 to 480 hours post-dose |
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 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 480 hours post-dose |
|
|
|
| Secondary | Time to Cmax (Tmax) | pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose | Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics. | Posted | Mean | Standard Deviation | h | 0 to 480 hours post-dose |
|
|
|
| 46 |
| 0 |
| 46 |
| 18 |
| 46 |
| EG001 | EU Sourced Enbrel in Part A | EU sourced Enbrel: SC administration | 0 | 46 | 0 | 46 | 16 | 46 |
| EG002 | SB4 in Part B | SB4: SC administration | 0 | 46 | 0 | 46 | 23 | 46 |
| EG003 | US Sourced Enbrel in Part B | US sourced Enbrel: SC administration | 0 | 46 | 0 | 46 | 20 | 46 |
| EG004 | EU Sourced Enbrel in Part C | EU sourced Enbrel: SC administration | 0 | 46 | 0 | 46 | 17 | 46 |
| EG005 | US Sourced Enbrel in Part C | US sourced Enbrel: SC administration | 0 | 46 | 0 | 46 | 14 | 46 |
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Lip erosion | Gastrointestinal disorders | Systematic Assessment |
|
| Injection site reaction | General disorders | Systematic Assessment |
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| Chest discomfort | General disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Rhinitis | Infections and infestations | Systematic Assessment |
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| Pharyngitis | Infections and infestations | Systematic Assessment |
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| Oral herpes | Infections and infestations | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sunburn | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Influenza like illness | General disorders | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | Systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | Systematic Assessment |
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| Erection increased | Reproductive system and breast disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Conjunctivitis | Eye disorders | Systematic Assessment |
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| Lip blister | Gastrointestinal disorders | Systematic Assessment |
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| Oral discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Folliculitis | Infections and infestations | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Ligament rupture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hot flush | Vascular disorders | Systematic Assessment |
|
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