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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Biological: US-approved Neulasta; Biological: PF-06881894

• Registration Number: NCT03273842
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-06
• Study Start: 2017-10-27
• Primary Completion: 2018-07-25
• Study Completion: 2018-07-25
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 422

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
US-approved Neulasta	US-approved Neulasta	US-approved Neulasta 6 mg SC
PF-06881894	PF-06881894	PF-06881894 6 mg SC

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (3)

Seaview A Quotient Clinical Business; 🇺🇸 Miami, Florida, United States

Quotient Sciences- Jacksonville, LLC; 🇺🇸 Jacksonville, Florida, United States

Vince & Associates Clinical Research Inc.; 🇺🇸 Overland Park, Kansas, United States