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This is a Phase I, Double-blind, Randomized, Parallel-group, Single-dose, Three-Arm Study to Compare the Pharmacokinetics and to Evaluate the Tolerability, Safety and Immunogenicity of JHL1149 and Bevacizumab (Avastin) Sourced from the European Union (EU) and the Union States (US) in Healthy Male Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JHL1149 | Experimental |
| |
| US-sourced-Avastin™ | Active Comparator |
| |
| EU-sourced Avastin™ | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JHL1149 | Biological | Each patient may receive single dose of JHL1149 1mg/kg by intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf | area under the concentration-time curve from time zero to infinity (AUC0-inf) | up to 71 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | Area under the serum concentration-time curve from time 0 to last quantifiable concentration (AUClast). | up to 71 days |
| Cmax | Maximum serum concentration just prior to end of infusion (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MHAT Lyulin EAD | Sofia | 1336 | Bulgaria |
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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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| Bevacizumab | Biological | Each patient may receive single dose of Avastin 1mg/kg by intravenous infusion |
|
| Bevacizumab | Biological | Each patient may receive single dose of Avastin 1mg/kg by intravenous infusion |
|
| up to 71 days |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |