Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001026-41 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab
A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab (SB8, EU Sourced Avastin®, and US Sourced Avastin®) in Healthy Male Subjects
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB8 | Experimental | SB8, single dose of 3 mg/kg, IV infusion |
|
| EU Sourced Avastin® | Active Comparator | EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion |
|
| US Sourced Avastin® | Active Comparator | US Sourced Avastin®, single dose of 3 mg/kg, IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB8 | Biological | SB8, proposed bevacizumab biosimilar |
| |
| EU sourced Avastin® |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) | 0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion. | 0 to 2016 hours after start of infusion |
| Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | 0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion. | 0 to 2016 hours after start of infusion |
| Maximum Serum Concentration (Cmax) | 0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion. | 0 to 2016 hours after start of infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Cmax (Tmax) | 0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion. | 0 to 2016 hours after start of infusion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Investigational Site | Antwerp | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32949267 | Derived | Shin D, Lee YJ, Choi J, Lee D, Park M, Petkova M. A phase I, randomized, single-dose pharmacokinetic study comparing sb8 (bevacizumab biosimilar) with reference bevacizumab in healthy volunteers. Cancer Chemother Pharmacol. 2020 Oct;86(4):567-575. doi: 10.1007/s00280-020-04144-7. Epub 2020 Sep 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SB8 (Proposed Bevacizumab Biosimilar) | SB8, single dose of 3 mg/kg, IV infusion SB8: SB8, proposed bevacizumab biosimilar |
| FG001 | EU Sourced Avastin® | EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion EU sourced Avastin®: EU sourced Avastin® (bevacizumab, Roche Registration Ltd.) |
| FG002 | US Sourced Avastin® | US Sourced Avastin®, single dose of 3 mg/kg, IV infusion US Sourced Avastin®: US Sourced Avastin® (bevacizumab, Roche Registration Ltd.) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SB8 (Proposed Bevacizumab Biosimilar) | SB8, single dose of 3 mg/kg, IV infusion SB8: SB8, proposed bevacizumab biosimilar |
| BG001 | EU Sourced Avastin® | EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion EU sourced Avastin®: EU sourced Avastin® (bevacizumab, Roche Registration Ltd.) |
| 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) | 0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion. | Among the subjects discountinued, subjects with major protocol deviations were excluded from the PK population for the PK analysis. | Posted | Mean | Standard Deviation | h·μg/mL | 0 to 2016 hours after start of infusion |
|
12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SB8 (Proposed Bevacizumab Biosimilar) | SB8, single dose of 3 mg/kg, IV infusion SB8: SB8, proposed bevacizumab biosimilar |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perirectal abscess | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Development | Samsung Bioepis | +82 31 8061 4534 | sbregistry@samsung.com |
Not provided
Not provided
Not provided
Not provided
Not provided
| Biological |
EU sourced Avastin® (bevacizumab, Roche Registration Ltd.) |
|
| US Sourced Avastin® | Biological | US Sourced Avastin® (bevacizumab, Roche Registration Ltd.) |
|
| BG002 | US Sourced Avastin® | US Sourced Avastin®, single dose of 3 mg/kg, IV infusion US Sourced Avastin®: US Sourced Avastin® (bevacizumab, Roche Registration Ltd.) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion
EU sourced Avastin®: EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)
| OG002 | US Sourced Avastin® | US Sourced Avastin®, single dose of 3 mg/kg, IV infusion US Sourced Avastin®: US Sourced Avastin® (bevacizumab, Roche Registration Ltd.) |
|
|
| Primary | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | 0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion. | Among the subjects discountinued, subjects with major protocol deviations were excluded from the PK population for the PK analysis. | Posted | Mean | Standard Deviation | h·μg/mL | 0 to 2016 hours after start of infusion |
|
|
|
| Primary | Maximum Serum Concentration (Cmax) | 0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion. | Among the subjects discountinued, subjects with major protocol deviations were excluded from the PK population for the PK analysis. | Posted | Mean | Standard Deviation | μg/mL | 0 to 2016 hours after start of infusion |
|
|
|
| Secondary | Time to Reach Cmax (Tmax) | 0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion. | Among the subjects discountinued, subjects with major protocol deviations were excluded from the PK population for the PK analysis. | Posted | Mean | Standard Deviation | h | 0 to 2016 hours after start of infusion |
|
|
|
| 0 |
| 40 |
| 1 |
| 40 |
| 20 |
| 40 |
| EG001 | EU Sourced Avastin® | EU Sourced Avastin®, single dose of 3 mg/kg, IV infusion EU sourced Avastin®: EU sourced Avastin® (bevacizumab, Roche Registration Ltd.) | 0 | 40 | 0 | 40 | 15 | 40 |
| EG002 | US Sourced Avastin® | US Sourced Avastin®, single dose of 3 mg/kg, IV infusion US Sourced Avastin®: US Sourced Avastin® (bevacizumab, Roche Registration Ltd.) | 0 | 39 | 0 | 39 | 21 | 39 |
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Influenza like illness | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Catheter site pain | General disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | Systematic Assessment |
|
| Oral herpes | Infections and infestations | Systematic Assessment |
|
| Otitis externa | Infections and infestations | Systematic Assessment |
|
| Paronychia | Infections and infestations | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided