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PF-06410293 PFS, PF-06410293 PFP

Phase 1

Healthy Subjects | Unknown | Other |Pfizer, Inc.|Last Updated: Jun 6, 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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment164
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02572245A Study of PF-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult SubjectsPHASE1 COMPLETED 164Jan 1, 2016May 1, 2016Jun 6, 20161 United States
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Study Endpoints
Primary Endpoints
Maximum serum concentration (Cmax)
Day 1 - Day 15
Area under the concentration curve (AUC 0-2wk)
Day 1-Day 15
Secondary Endpoints
Injection site tolerability (Subject Assessment - Visual Analog Scale) - Mean Injection site pain over 24 hour period post dose
Hour 0 (immediately after injection), 15 minutes, 1, 3, 8, 12 and 24 hours post injection
Injection site tolerability (Blinded Safety Assessor - Modified Draize Scale) - Mean injection site tolerability over 24 hour post dose
1, 3, 8, 12 and 24 hours post injection
Time to reach the maximum serum concentration (Tmax)
Day 1 - Day 43
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-06410293 PFS (Prefilled Syringe)ACTIVE_COMPARATORPF-06410293 40 mg administered by Prefilled Syringe (PFS)
PF-06410293 PFP (Prefilled Pen)ACTIVE_COMPARATORPF-06410293 40 mg administered by Prefilled pen
Interventions
NameTypeDescription
PF-06410293 PFSDEVICEPF-06410293 40 mg administered subcutaneously by Prefilled syringe
PF-06410293 PFPDEVICEPF-06410293 40 mg administered subcutaneously by prefilled pen
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy female subjects and/or male subjects, who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood ...

Countries:United States
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