Healthy
Conditions
Keywords
Trastuzumab, Healthy Male Volunteers, Single-Dose, Phase 1, Biosimilarity
Brief summary
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.
Detailed description
Safety evaluation.
Interventions
BIOLOGICALPF-05280014
Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1
BIOLOGICALHerceptin®
Concentrate for solution for infusion, sterile vial 440 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index (BMI) of 17.5 to 30.5 kg\^m2; and a total body weight \>50 kg (110 lbs). * Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiogram (ECHO) within 8 weeks prior to randomization. * Subjects who have previously been exposed to a biologic agent (other than a HER2 inhibitor) may enroll provided that at least 3 months have passed since the last administration of that drug.
Exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * Previous exposure to an anti-HER2 antibody. * History of serious allergic or anaphylactic reaction to a therapeutic drug or benzyl alcohol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of body temperature greater than or equal to 38.0 degrees Celsius | within 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Severity of pyrexia | within 24 hours |
| Timing of pyrexia | within 24 hours |
| Incidence of pyrexia | within 24 hours |
| Relationship of study therapy to pyrexia | 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 | within 24 hours |
| Seriousness of pyrexia | within 24 hours |
Countries
United States
Outcome results
None listed