A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: PF-05280014

Biological: Herceptin®

Study type

Interventional

Funder types

Industry

Identifiers

NCT02015156

B3271006

REFLECTIONS B327-06

Details and patient eligibility

About

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.

Full description

Safety evaluation.

Enrollment

162 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.