A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/1/2014 |
| Start Date: | January 2014 |
| End Date: | February 2014 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 2-Arm, Safety Study Of PF-05280014 And Trastuzumab Sourced From The US Administered To Healthy Male Volunteers
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.
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.
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.
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