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This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product CT-P16 with EU-approved Avastin and US-licensed Avastin after a single IV infusion of 5mg/kg of each product to healthy male subjects
This study is a double-blind, three-arm, parallel group, single-dose study. A total of 141 subjects will be enrolled; 47 subjects in each of the 3 arms of the clinical study. In each arm, all subjects will receive a single dose (5 mg/kg) of either CT-P16, EU-approved Avastin, or US-licensed Avastin by intravenous (IV) infusion for 90 min (±5 min) on Day 1 followed by 15 weeks during which the PK, safety, and immunogenicity measurements will be made. The randomization will be stratified by body weight and site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P16 | Experimental | CT-P16 will be administrated once in IV infusion of 5mg/KG to healthy male subjects |
|
| EU-approved Avastin | Active Comparator | EU-approved Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects |
|
| US-licensed Avastin | Active Comparator | US-licensed Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P16 | Drug | CT-P16 is a biosimilar product for Avastin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf | Area under the concentration-time curve from time zero to infinity | pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI |
| Cmax | Maximum Serum Concentration (Cmax) | pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI |
| AUC0-last | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration | pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Pharmacokinetics (Time to Cmax) | To assess the additional PK of study drugs (Time to Cmax) | pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI |
| Number of Participants With Anti-Drug Antibody Positive |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sung Young Lee | Celltrion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | South Korea | ||||
| Inha University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30850957 | Derived | Cho SH, Han S, Ghim JL, Nam MS, Yu S, Park T, Kim S, Bae J, Shin JG. A Randomized, Double-Blind Trial Comparing the Pharmacokinetics of CT-P16, a Candidate Bevacizumab Biosimilar, with its Reference Product in Healthy Adult Males. BioDrugs. 2019 Apr;33(2):173-181. doi: 10.1007/s40259-019-00340-x. |
| Label | URL |
|---|---|
| Celltrion, Inc. homepage | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | CT-P16 | CT-P16 will be administrated once in IV infusion of 5mg/kg to healthy male subjects CT-P16: CT-P16 is a biosimilar product for Avastin |
| FG001 | EU-approved Avastin | EU-approved Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects EU-approved Avastin: EU-approved Avastin |
| FG002 | US-licensed Avastin | US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects US-licensed Avastin: US-licensed Avastin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | CT-P16 | CT-P16 will be administrated once in IV infusion of 5mg/kg to healthy male subjects CT-P16: CT-P16 is a biosimilar product for Avastin |
| BG001 | EU-approved Avastin | EU-approved Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects EU-approved Avastin: EU-approved Avastin |
| 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 | AUC0-inf | Area under the concentration-time curve from time zero to infinity | PK population | Posted | Mean | Standard Deviation | h*ug/mL | pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI |
|
up to 15 weeks
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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 | CT-P16 | CT-P16 will be administrated once in IV infusion of 5mg/kg to healthy male subjects CT-P16: CT-P16 is a biosimilar product for Avastin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
Subject with unreliable PK parameter results were excluded from summary. Only treatment-emergent adverse events were summarized.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Planning Department Leader | Celltrion | 82328505000 | contact@celltrion.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 29, 2018 | Feb 19, 2020 | SAP_002.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 7, 2017 | Mar 3, 2020 | Prot_003.pdf |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| EU-approved Avastin | Drug | EU-approved Avastin |
|
|
| US-licensed Avastin | Drug | US-licensed Avastin |
|
|
number of participants with anti-drug antibody positive at post-dose |
| up to 15 weeks |
| Incheon |
| South Korea |
| Seoul St.Mary's hospital | Seoul | South Korea |
| BG002 | US-licensed Avastin | US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects US-licensed Avastin: US-licensed Avastin |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| BMI | kg/m2 | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | US-licensed Avastin | US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects US-licensed Avastin: US-licensed Avastin |
|
|
| Primary | Cmax | Maximum Serum Concentration (Cmax) | PK population | Posted | Mean | Standard Deviation | ug/mL | pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI |
|
|
|
| Primary | AUC0-last | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration | PK population | Posted | Mean | Standard Deviation | h*ug/mL | pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI |
|
|
|
| Secondary | Additional Pharmacokinetics (Time to Cmax) | To assess the additional PK of study drugs (Time to Cmax) | PK population | Posted | Median | Full Range | h | pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI |
|
|
|
| Secondary | Number of Participants With Anti-Drug Antibody Positive | number of participants with anti-drug antibody positive at post-dose | Safety Population | Posted | Count of Participants | Participants | up to 15 weeks |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 15 |
| 46 |
| EG001 | EU-approved Avastin | EU-approved Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects EU-approved Avastin: EU-approved Avastin | 0 | 47 | 0 | 47 | 22 | 47 |
| EG002 | US-licensed Avastin | US-licensed Avastin will be administrated once in IV infusion of 5mg/kg to healthy male subjects US-licensed Avastin: US-licensed Avastin | 0 | 48 | 0 | 48 | 17 | 48 |
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Infusion-related reaction | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Troponin I increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |