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| Name | Class |
|---|---|
| Almedis | INDUSTRY |
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The purpose of this study is to confirm pharmacokinetic equivalence and compare clinical safety profile of RPH-001 and Avastin®.
The study will be conducted in one specialized clinical site in Russia. It is planned to randomize 80 healthy male volunteers in this study. After screening period, not exceeding 15 days, all eligible subjects will be hospitalized to the site and randomized to receive RPH-001 or Avastin in 1:1 ratio. After a single-dose of investigational drugs administration subjects will remain under the observation in clinical site for 8 days and then will be discharged. The out-patient follow up period will include at least 8 scheduled subject's visits to the site. The study will consider completed for each subject at Day 100 visit after all clinical study procedures completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RPH-001 | Experimental | Humanized recombinant monoclonal anti-VEGF antibody. 5 mg/kg single intravenous infusion (for no less than 90 minutes) |
|
| Avastin | Active Comparator | Humanized recombinant monoclonal anti-VEGF antibody. 5 mg/kg single intravenous infusion (for no less than 90 minutes) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPH-001 | Biological | Concentrate for preparation solution for infusion in ampules, 25 mg/mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum concentration of investigational drug achieved during sampling | 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion |
| AUC(0-t) | Area Under the Concentration-time curve from time 0 to the time of the last sample with measurable concentration | 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion |
| AUC(0-∞) | Area Under the Concentration-time curve from time 0 extrapolated to infinite time | 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion |
| Measure | Description | Time Frame |
|---|---|---|
| tmax | Time at which Cmax is attained | 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion |
| t1/2 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Anti-drug-antibodies (ADA), Neutralizing antibodies (NAb) | 30 minutes before and 336, 672, 1344, 1680 and 2376 hours after the start of investigational product infusion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikhail Samsonov | R-Pharm | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SBHI Krasnogorskaya City Hospital #1 | Krasnogorsk | Russia |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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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| Avastin | Biological | Concentrate for preparation solution for infusion in ampules, 25 mg/mL |
|
|
The terminal half-life |
| 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after after the start of investigational product infusion |
| λz | Elimination rate constant | 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion |
| Vz | Apparent Volume of Distribution | 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |