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U.S.-approved Neupogen

Phase 1

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

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

U.S.-approved Neupogen · 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 U.S.-approved Neupogen

What is Neupogen used for?

Neupogen is used for neutropenia, a condition of low white blood cell count. It is also studied in healthy volunteers to assess immune response and pharmacokinetics. The drug is a monoclonal antibody developed by Pfizer, Inc. (PFE) and is currently in Phase 1 clinical development.

Who makes Neupogen?

Neupogen is developed by Pfizer, Inc., which trades under the ticker PFE. The drug is a monoclonal antibody being studied for neutropenia and in healthy volunteers. It is currently in Phase 1 clinical trials.

What phase is Neupogen in?

Neupogen is in Phase 1 clinical development. It has completed two Phase 1 trials, with no active trials currently ongoing. The drug is investigational and not yet approved for any indication.

What clinical trials is Neupogen in?

Neupogen has been studied in three completed Phase 1 trials: NCT02766634, NCT02766647, and NCT02923791. These trials evaluated the drug in healthy volunteers and in subjects with neutropenia, with total enrollment of 256 participants across all studies.

Is Neupogen the same as Filgrastim Hospira?

Neupogen is used as a reference product in trials comparing it to Filgrastim Hospira. The trials NCT02766634 and NCT02766647 test Filgrastim Hospira against the already U.S.-approved Neupogen, while NCT02923791 assesses immune response to both products.