A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers

Status:	Completed
Conditions:	Healthy Studies
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - 65
Updated:	9/7/2018
Start Date:	October 27, 2017
End Date:	July 25, 2018

Phase 1, Randomized Open Label, Multiple Dose, Parallel Study To Assess The Immunogenicity Of Multiple Subcutaneous (SC) Doses Of The Proposed Pegfilgrastim Biosimilar (PF-06881894) And Us-approved Neulasta (Registered) In Healthy Volunteers

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.

Inclusion Criteria:

• Healthy males or females between 18 and 65 years of age (both inclusive) with body mass
index between 19 and 30 kg/m2, inclusive, and body weight of not <50 kg or >95 kg, will be
enrolled in this study.

Exclusion Criteria:

- Hematologic laboratory abnormalities (including leukocytosis [defined as total
leukocytes >11,000/mcL], leukopenia [defined as total leukocytes <4000/mcL], or
neutropenia [defined as absolute neutrophil count <1500/mcL] or thrombocytopenia
[defined as platelet count of <150,000/mcL]) or other clinically significant abnormal
laboratory evaluations.

- Lack of adequate hepatic or renal reserve.

- Any active systemic or immunologic disease or condition.

- History of biological growth factor exposure.

- Received live vaccination or exposure to communicable viral diseases within 4 weeks
prior to Screening.

We found this trial at

sites

Vince and Associates Clinical Research

Overland Park, Kansas 23112

from

Overland Park, KS