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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Biological: PF-06881894

Biological: US-approved Neulasta

Study type

Interventional

Funder types

Industry

Identifiers

NCT03273842

C1221005

IMM HSP-130 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

422 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.