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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273842
• Other study ID #: C1221005
• Secondary ID: IMM HSP-130
• Status: Completed
• Phase: Phase 1
• Start date: October 27, 2017
• Est. completion date: July 25, 2018

Study information

• Verified date: September 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: July 25, 2018
• Est. primary completion date: July 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Biological:
• PF-06881894
pre-filled syringe 6 mg
• US-approved Neulasta
pre-filled syringe 6 mg

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)

External Links

•   To obtain contact information for a study center near you, click here.