- 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.
- 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