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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03273842

Enrollment

422

Registered

2017-09-06

Start date

2017-10-27

Completion date

2018-07-25

Last updated

2018-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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.

Interventions

BIOLOGICALPF-06881894

pre-filled syringe 6 mg

BIOLOGICALUS-approved Neulasta

pre-filled syringe 6 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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.	90 days (through Period 1 Day1 to Period 2 Day 60 or final visit)

Secondary

Measure	Time frame
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.	90 Days (through Period 1 Day 1 to Period 2 Day 60 or final study visit)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026