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The study was withdrawn prior to enrollment after a comprehensive review of the biosimilars market and the company's global manufacturing network.
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This is a double-blind, randomized (1:1), parallel group, single dose, 2-arm, comparative PK study of PF-06439535 (CN) and bevacizumab-EU administered intravenously to Chinese healthy male volunteers. Approximately 66 subjects will be enrolled to ensure that at least 58 subjects (29 per arm) complete the study procedures and have evaluable PK data. The study will be conducted at 1 center in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference: bevacizumab - EU | Active Comparator |
| |
| Test: PF-06439535 (CN) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06439535 (CN) | Drug | This is the test drug Pfizer biosimilar of bevacizumab-EU. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t (Area under the serum concentration-time profile from time 0 to last time point with quantifiable concentration) | From Day 1 to Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum observed concentration derived from serum) | From Day 1 to Day 71 | |
| AUCinf (Area under the serum concentration-time profile from time zero extrapolated to infinity) | From Day 1 to Day 71 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital,Fudan University | Shanghai | Shanghai Municipality | 201107 | China |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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 - EU | Drug | This is the reference drug bevacizumab sourced from EU |
|
| terminal half-life (t1/2) | From Day 1 to Day 71 |
| clerance (CL) | From Day 1 to Day 71 |
| steady state volume of distribution (Vss) | From Day 1 to Day 71 |
| Percentage of participants with treatment emergent adverse events | From screening until Day 71 (total period of approximately 99 days) |
| Percentage of participants with clinical laboratory test results above/below certain threshold | At screening; Days -1, 2, 8, 29, 71 |
| Incidence of anti-drug antibodies (ADA) | From day 1 to day 71 |
| Incidence of neutralizing antibodies (Nab) | From Day 1 to Day 71 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |