This study compares the immune response to the proposed biosimilar PF-06881894 and the US-approved Neulasta reference product. Subjects will receive 2 subcutaneous injections (6 milligrams \[mg\]) either 1 of the 2 study drugs. Subjects will receive the first dose on Day 1 of Period 1 and the second dose on Day 1 of Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be conducted each of the two treatment periods. In addition, safety assessments will be conducted throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
422
pre-filled syringe 6 mg
pre-filled syringe 6 mg
Seaview A Quotient Clinical Business
Coral Gables, Florida, United States
Quotient Sciences- Jacksonville, LLC
Jacksonville, Florida, United States
Seaview A Quotient Clinical Business
Miami, Florida, United States
Vince & Associates Clinical Research Inc.
Overland Park, Kansas, United States
The proportion of subjects with a negative baseline anti-pegfilgrastim antibody test result and confirmed postdose positive anti-pegfilgrastim antibody test result at any time during the study.
Time frame: 90 days (through Period 1 Day1 to Period 2 Day 60 or final visit)
The proportion of subjects with a negative baseline anti-pegfilgrastim antibody test result and postdose positive neutralizing antibody result at any time during the study.
Time frame: 90 Days (through Period 1 Day 1 to Period 2 Day 60 or final study visit)
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