NCT03273842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
422

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2017

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 27, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2018

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

September 5, 2017

Last Update Submit

September 4, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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)

Study Arms (2)

PF-06881894

EXPERIMENTAL

PF-06881894 6 mg SC

Biological: PF-06881894

US-approved Neulasta

ACTIVE COMPARATOR

US-approved Neulasta 6 mg SC

Biological: US-approved Neulasta

Interventions

PF-06881894BIOLOGICAL

pre-filled syringe 6 mg

PF-06881894
US-approved NeulastaBIOLOGICAL

pre-filled syringe 6 mg

US-approved Neulasta

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Seaview A Quotient Clinical Business

Coral Gables, Florida, 33134, United States

Location

Quotient Sciences- Jacksonville, LLC

Jacksonville, Florida, 32256, United States

Location

Seaview A Quotient Clinical Business

Miami, Florida, 33126, United States

Location

Vince & Associates Clinical Research Inc.

Overland Park, Kansas, 66212, United States

Location

Related Publications (1)

  • 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.

    PMID: 32524499DERIVED

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 6, 2017

Study Start

October 27, 2017

Primary Completion

July 25, 2018

Study Completion

July 25, 2018

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests

Locations

US(4)