Clinical trial NCT03273842: A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-09-06
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 90 days (through Period 1 Day1 to Period 2 Day 60 or final visit)
Secondary outcomes:
measure: 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.
timeFrame: 90 Days (through Period 1 Day 1 to Period 2 Day 60 or final study visit)
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Seaview A Quotient Clinical Business
state: Florida
city: Jacksonville
country: United States
facility: Quotient Sciences- Jacksonville, LLC
state: Florida
city: Miami
country: United States
facility: Seaview A Quotient Clinical Business
state: Florida
city: Overland Park
country: United States
facility: Vince & Associates Clinical Research Inc.
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Moosavi S, Borema T, Ewesuedo R, Harris S, Levy J, May TB, Summers M, Thomas JS, Zhang J, Yao HM. PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta(R)): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers. Adv Ther. 2020 Jul;37(7):3370-3391. doi: 10.1007/s12325-020-01387-x. Epub 2020 Jun 10.