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

NCT02015156 | Completed Phase 1

• 2 other identifiers: B3271006REFLECTIONS B327-06
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

Trastuzumab; Healthy Male Volunteers; Single-Dose; Phase 1; Biosimilarity

Outcome Measures

Primary Outcomes (1)

• Incidence of body temperature greater than or equal to 38.0 degrees Celsius

  within 24 hours

Secondary Outcomes (6)

• 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

Study Arms (2)

PF-05280014

EXPERIMENTAL

Biological: PF-05280014

Trastuzumab-US

ACTIVE COMPARATOR

Biological: Herceptin®

Interventions

PF-05280014 BIOLOGICAL

Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1

Also known as: Trastuzumab-Pfizer

PF-05280014

Herceptin® BIOLOGICAL

Concentrate for solution for infusion, sterile vial 440 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1

Also known as: Trastuzumab-US

Trastuzumab-US

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Overland Park, Kansas, 66211, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66212, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

PF-05280014; Trastuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 19, 2013
• Study Start: January 1, 2014
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 23, 2014

Record last verified: 2014-04

Locations

US (2)