Healthy
Conditions
Keywords
Bioequivalence, Biosimilarity, Similarity, PK, Phase 1, Bevacizumab, Healthy Volunteers, Single-Dose, Oncology
Brief summary
This study is to prove that the handling (also referred to as pharmacokinetics) of the following drugs PF-06439535, Avastin® (bevacizumab) that is licensed for use in the United States (bevacizumab-US) and Avastin® (bevacizumab) obtained from Europe (bevacizumab-EU) is similar in healthy male volunteers after receiving a single intravenous dose of either drugs. During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06439535, bevacizumab-US and bevacizumab-EU. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.
Interventions
BIOLOGICALPF-06439535
Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
BIOLOGICALAvastin
Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
21 Years to 55 Years
Healthy volunteers
Yes
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 * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50kg (110lbs)
Exclusion criteria
* Evidence or history of a clinically significant disease or clinical finding at Screening * Previous treatment with an anti-VEGF antibody, or any other antibody or protein targeting the VEGF receptor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Day 1 - Day 71 | — |
| Area Under the Curve from Time Zero to end of dosing interval (AUCtau) | Day 1 - Day 71 | — |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | Day 1 - Day 71 | 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). |
Secondary
| Measure | Time frame |
|---|---|
| Systemic Clearance (CL) | Day 1 - Day 71 |
| Incidence of anti-bevacizumab antibodies (ADA), including neutralizing antibodies (Nab) | Day 1 - Day 71 or LSLV, whichever occurs later |
| Terminal Disposition Half-Life (t1/2) | Day 1 - Day 71 |
| Volume of Distribution at Steady State (Vss) | Day 1 - Day 71 |
Countries
United States
Outcome results
None listed