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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004112-21 | EudraCT Number |
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The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB3 | Experimental | SB3, single dose of 6 mg/kg via intravenous infusion (study drug) |
|
| EU sourced Herceptin® | Active Comparator | EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug) |
|
| US sourced Herceptin® | Active Comparator | US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB3 | Biological |
| ||
| EU sourced Herceptin® |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) | 57 days | |
| Maximum Serum Concentration (Cmax) | 57 days | |
| Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | 57 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cmax (Tmax) | 57 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saumsung Bioepis | Samsung Bioepis Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Investigational Site | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27368117 | Derived | Pivot X, Curtit E, Lee YJ, Golor G, Gauliard A, Shin D, Kim Y, Kim H, Fuhr R. A Randomized Phase I Pharmacokinetic Study Comparing Biosimilar Candidate SB3 and Trastuzumab in Healthy Male Subjects. Clin Ther. 2016 Jul;38(7):1665-1673.e3. doi: 10.1016/j.clinthera.2016.06.002. Epub 2016 Jun 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SB3 (Proposed Trastuzumab Biosimilar) | SB3, single dose of 6 mg/kg via intravenous infusion (study drug) SB3 |
| FG001 | EU Sourced Herceptin® | EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug) EU sourced Herceptin® |
| FG002 | US Sourced Herceptin® | US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug) US sourced Herceptin® |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SB3 (Proposed Trastuzumab Biosimilar) | SB3, single dose of 6 mg/kg via intravenous infusion (study drug) SB3 |
| BG001 | EU Sourced Herceptin® | EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug) EU sourced Herceptin® |
| 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 | µg·h/mL | 57 days |
|
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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 | SB3 (Proposed Trastuzumab Biosimilar) | SB3, single dose of 6 mg/kg via intravenous infusion (study drug) SB3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Development | Samsung Bioepis | +82 31 8061 4534 |
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|
| US sourced Herceptin® | Biological |
|
| BG002 | US Sourced Herceptin® | US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug) US sourced Herceptin® |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Maximum Serum Concentration (Cmax) | Posted | Mean | Standard Deviation | µg/mL | 57 days |
|
|
|
| Primary | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | Posted | Mean | Standard Deviation | µg·h/mL | 57 days |
|
|
|
| Secondary | Time to Cmax (Tmax) | Posted | Mean | Standard Deviation | hour | 57 days |
|
|
|
| 0 |
| 36 |
| 1 |
| 36 |
| 25 |
| 36 |
| EG001 | EU Sourced Herceptin® | EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug) EU sourced Herceptin® | 0 | 36 | 0 | 36 | 23 | 36 |
| EG002 | US Sourced Herceptin® | US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug) US sourced Herceptin® | 0 | 36 | 0 | 36 | 25 | 36 |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Gastric disorder | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Proctalgia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Affect lability | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
Project results may not be published or referred to, in whole or in part, by the Service Provider or any of its Affiliates without the prior expressed written consent of Sponsor, which will not be unreasonably withheld or delayed. Neither Party shall use the other Party's name in connection with any publication or promotion without the other Party's prior written consent.