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US-Approved Neupogen

Phase 1

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

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment256
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02923791A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product.PHASE1 COMPLETED 256 — — Oct 1, 2016Jan 1, 2017Feb 23, 20173 United States
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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)
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)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Filgrastim HospiraEXPERIMENTAL -
US-Approved NeupogenACTIVE_COMPARATOR -
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.
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Eligibility Criteria
Age Range18 Years — 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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