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Filgrastim Hospira

Phase 1

Neutropenia (Low White Blood Cell Count) | Monoclonal antibody | Hematology |Pfizer, Inc.|Trials Updated: Jul 21, 2016

Filgrastim Hospira development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2016

Filgrastim Hospira target and mechanism

Molecular targetCSF3R
Target classAgonist
ModalityMonoclonal antibody
ChEMBLCHEMBL1201567

Also known as Filgrastim Hospira (US)

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment84

FDA Designations

No designations recorded

Filgrastim Hospira clinical trials

Filgrastim Hospira · 2 trials · 1 indication

Phase 1 2
NCT02766634A Research Study To Test How Multiple Doses Of Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given by Subcutaneous Injection (SC) (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)Neutropenia (Low White Blood Cell Count)
COMPLETED60 Analytics
NCT02766647A Research Study To Test How Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given By Subcutaneous Injection (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)Neutropenia (Low White Blood Cell Count)
COMPLETED24 Analytics
PHASE1COMPLETED
A Research Study To Test How Multiple Doses Of Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given by Subcutaneous Injection (SC) (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)
Neutropenia (Low White Blood Cell Count)
NCT0276663460
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PHASE1COMPLETED
A Research Study To Test How Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given By Subcutaneous Injection (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)
Neutropenia (Low White Blood Cell Count)
NCT0276664724
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Study Endpoints

Primary Endpoints

The Area under the effect curve for CD34+ (AUECCD34+)
prior to study drug administration on Days 1, 2, 3, 4, 5, and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period
Maximum observed value for CD34+ (CD34+max)
prior to study drug administration on Days 1, 2, 3, 4, 5, and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period
Area under the serum filgrastim concentration versus time curve from time zero to 24 hours (AUC0-24)
prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period
Maximum serum filgrastim concentration (Cmax) following study drug administration on Day 5
prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period
Area under the serum filgrastim concentration versus time curve from zero to infinity (AUC0-∞)
1 hour prior to dose administration and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours after dose administration
Maximum serum filgrastim concentration (Cmax)
1 hour prior to dose administration and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, and 48 hours after dose administration
Area under the effect curve for Absolute Neutrophil Count (ANC) (AUEC ANC)
1 hour prior to dose administration and 0.5, 1, 2, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dose administration
Maximum observed ANC ( ANC max)
1 hour prior to dose administration and 0.5, 1, 2, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dose administration

Secondary Endpoints

Time to maximum CD34+ count (Tmax[CD34+])
prior to study drug administration on Days 1, 2, 3, 4, 5, and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period
The concentration prior to dose on Day 5 (Ctrough)
prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period.
Time to maximum serum filgrastim concentration (Tmax)
prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Filgrastim Hospira (US) followed by U.S.-approved Neupogen®EXPERIMENTAL -
U.S.-approved Neupogen® followed by Filgrastim Hospira (US)EXPERIMENTAL -

Interventions

NameTypeDescription
Filgrastim Hospira (US)BIOLOGICAL5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection once a day for 5 days
U.S.-approved Neupogen®BIOLOGICAL5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection once a day for 5 days
US-approved Neupogen®BIOLOGICAL5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: A subject will be eligible for study participation if all of the following criteria are met at Screening: 1. Provides written informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB) prior to any study related activities 2. Healthy ma...

Countries:United States
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Frequently asked questions about Filgrastim Hospira

What is Filgrastim Hospira used for?

Filgrastim Hospira is being studied for neutropenia, a condition marked by low white blood cell counts. It is a proposed biosimilar to Neupogen, and the clinical work to date has focused on comparing how the two products behave in the body rather than on treating patients directly.

How does Filgrastim Hospira work?

Filgrastim Hospira targets CSF3R, also known as the granulocyte colony stimulating factor receptor, and acts as an agonist at that receptor. Stimulating CSF3R drives the production and maturation of neutrophils, the white blood cells that defend against infection, which is the basis for its use in neutropenia.

Who makes Filgrastim Hospira?

Filgrastim Hospira is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The product is a proposed biosimilar version of Neupogen, the Amgen filgrastim product already approved in the United States.

What phase is Filgrastim Hospira in?

Filgrastim Hospira is in Phase 1 development. It is investigational and has not been approved by the FDA. The two recorded Phase 1 studies have both been completed, and no trials are currently active.

What clinical trials is Filgrastim Hospira in?

Filgrastim Hospira has been studied in two completed Phase 1 trials, NCT02766647 and NCT02766634, both run in the United States in healthy adult volunteers. Together they enrolled 84 participants and compared subcutaneous Filgrastim Hospira with the already US-approved Neupogen.

Is Filgrastim Hospira the same as Neupogen?

Filgrastim Hospira is not the same as Neupogen, though it is developed as a proposed biosimilar to it. Neupogen is Amgen's approved filgrastim product, while Filgrastim Hospira is Pfizer's investigational version, also referred to as Filgrastim Hospira (US).

Other drugs targeting CSF3R

Filgrastim AMGN· PHASE2 Pegfilgrastim AMGN· PHASE3 Eflapegrastim ASRT· PHASE2 CHS-1701 CHRS· PHASE1 Pegfilgrastim Hospira PFE· PHASE1 Balugrastim TEVA· PHASE2 Lipegfilgrastim TEVA· PHASE3 tbo-filgrastim TEVA· PHASE2

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