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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment84
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
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)PHASE1 COMPLETED 60 — — Mar 1, 2016Jun 1, 2016Jul 21, 20162 United States
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)PHASE1 COMPLETED 24 — — Dec 1, 2015Mar 1, 2016May 10, 20161 United States
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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 — 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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