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Filgrastim Hospira

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Feb 23, 2017

Target and mechanism

ModalityMonoclonal antibody

Also known as Filgrastim Hospira (US)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment256

FDA Designations

No designations recorded

Clinical trial landscape

Filgrastim Hospira · 3 trials · 2 indications

Phase 1 3
NCT02923791A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product.Healthy Volunteers
COMPLETED256 Analytics
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 Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product.
Healthy Volunteers
NCT02923791256
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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 proportion of subjects with a negative baseline anti-drug antibody (ADA) test result and confirmed post-dose positive ADA test result at any time during the study.
62 days (Period 1 Day 0 through Period 2 Day 31 or Final Visit)
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

The proportion of subjects with a negative baseline ADA test result and post-dose positive neutralizing antibody result at any time during the study;
62 days (Period 1 Day 0 through Period 2 Day 31 or Final Visit)
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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

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

Interventions

NameTypeDescription
Filgrastim HospiraBIOLOGICAL5 consecutive daily doses (Days 1-5) in Period 1 and 1 dose (Day 1) in Period 2.
US-Approved NeupogenBIOLOGICAL5 consecutive daily doses (Days 1-5) in Period 1 and 1 dose (Day 1) in Period 2.
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 Sites3

Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Healt...

Countries:United States
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