Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-06439535 · 1 trial · 1 indication
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
| Arm | Type | Description |
|---|---|---|
| A = PF-06439535 | EXPERIMENTAL | Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. |
| B = Bevacizumab-EU | ACTIVE_COMPARATOR | Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. |
| C = Bevacizumab-US | ACTIVE_COMPARATOR | Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. |
| Name | Type | Description |
|---|---|---|
| PF-06439535 | BIOLOGICAL | Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion. |
| Avastin | BIOLOGICAL | Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion. |
Inclusion Criteria: * Healthy male subjects 21-55 years old * Subjects who have previously been exposed to a biologic agent (other than a VEGF \[Vascular Endothelial Growth Factor Receptor\] inhibitor) may enroll provided that at least 3 months have passed since the last administration of that drug...
PF-06439535 is an investigational monoclonal antibody being studied in healthy volunteers. It is being evaluated in a pharmacokinetic study to compare its properties with bevacizumab in healthy male subjects. The drug is not approved for any indication and is currently in clinical development.
PF-06439535 is a monoclonal antibody that is being compared with bevacizumab, a drug that targets vascular endothelial growth factor (VEGF). While the specific molecular target of PF-06439535 is not explicitly stated, its comparison with bevacizumab suggests it may share a similar mechanism of action.
PF-06439535 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's pharmacokinetics in healthy volunteers.
PF-06439535 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 1 trial that enrolled 102 healthy male volunteers.
PF-06439535 has one completed clinical trial, NCT02031991, titled "A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01)." This Phase 1 study enrolled 102 healthy male participants in the United States and was active-controlled and double-blind.
PF-06439535 is not the same as bevacizumab, but it is being studied in comparison with bevacizumab. The clinical trial NCT02031991 was designed to compare the pharmacokinetics of PF-06439535 and bevacizumab in healthy male volunteers, indicating they are distinct drugs being evaluated for potential similarity.