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PF-06881894

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Sep 5, 2018

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_CONTROLLED
Total Trials1
Total Enrollment422
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03273842A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy VolunteersPHASE1 COMPLETED 422 — — Oct 27, 2017Jul 25, 2018Sep 5, 20184 United States
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Study Endpoints
Primary Endpoints
The proportion of subjects with a negative baseline anti-pegfilgrastim antibody test result and confirmed postdose positive anti-pegfilgrastim antibody test result at any time during the study.
90 days (through Period 1 Day1 to Period 2 Day 60 or final visit)
Secondary Endpoints
The proportion of subjects with a negative baseline anti-pegfilgrastim antibody test result and postdose positive neutralizing antibody result at any time during the study.
90 Days (through Period 1 Day 1 to Period 2 Day 60 or final study visit)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
PF-06881894EXPERIMENTALPF-06881894 6 mg SC
US-approved NeulastaACTIVE_COMPARATORUS-approved Neulasta 6 mg SC
Interventions
NameTypeDescription
PF-06881894BIOLOGICALpre-filled syringe 6 mg
US-approved NeulastaBIOLOGICALpre-filled syringe 6 mg
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: • Healthy males or females between 18 and 65 years of age (both inclusive) with body mass index between 19 and 30 kg/m2, inclusive, and body weight of not \<50 kg or \>95 kg, will be enrolled in this study. Exclusion Criteria: * Hematologic laboratory abnormalities (including ...

Countries:United States
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