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

Study Overview
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Brief Summary
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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
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Safety evaluation.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Biological: PF-05280014
* Biological: Herceptin®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-05280014<br> | Biological: PF-05280014<br>* Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1<br>* Other names: Trastuzumab-Pfizer;|
| Active Comparator: Trastuzumab-US<br> | Biological: Herceptin®<br>* Concentrate for solution for infusion, sterile vial 440 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1<br>* Other names: Trastuzumab-US;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of body temperature greater than or equal to 38.0 degrees Celsius |  | within 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pyrexia |  | within 24 hours | 
| Severity of pyrexia |  | within 24 hours | 
| Timing of pyrexia |  | within 24 hours | 
| Seriousness 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trastuzumab, Healthy Male Volunteers, Single-Dose, Phase 1, Biosimilarity