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PF-06730512

Phase 1

Healthy | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: May 22, 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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment79
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03146065Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of PF-06730512PHASE1 COMPLETED 79 — — May 10, 2017May 3, 2018May 22, 20181 Belgium
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Study Endpoints
Primary Endpoints
Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s)
Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with injection site reaction(s)
Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with laboratory test findings of potential clinical importance
Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with vital signs findings of potential clinical importance
Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with ECG findings of potential clinical importance
Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Secondary Endpoints
Maximum Observed Plasma Concentration (Cmax) of PF-06730512
Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512
Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06730512
Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-06730512EXPERIMENTALStudy Drug being used in the study
PlaceboPLACEBO_COMPARATORPlacebo for IV/SC administration
Interventions
NameTypeDescription
PF-06730512BIOLOGICALComparison of different dosages of PF-06730512 to Placebo
PlaceboDRUGComparison of Placebo to different doses of PF-06730512
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy female subjects of nonchildbearing potential 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, full physical exami...

Countries:Belgium
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