This study is to prove that there is no difference in the number of healthy male volunteers that will experience pyrexia (i.e. fever with body temperature of 38°C or higher) within a 24 hour period after administration of a single dose of 6mg/kg of PF-05280014 or trastuzumab sourced from the United States (trastuzumab-US). The study will also compare the safety of both drugs.
Safety evaluation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
162
Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1
Concentrate for solution for infusion, sterile vial 440 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Incidence of body temperature greater than or equal to 38.0 degrees Celsius
Time frame: within 24 hours
Incidence of pyrexia
Time frame: within 24 hours
Severity of pyrexia
Time frame: within 24 hours
Timing of pyrexia
Time frame: within 24 hours
Seriousness of pyrexia
Time frame: within 24 hours
Relationship of study therapy to pyrexia
Time frame: within 24 hours
Incidence of body temperature greater than or equal to 38.0°C and/or use of concomitant treatment associated with fever suppression
Time frame: within 24 hours
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