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PF-06252616

Phase 1

Healthy | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Sep 25, 2014

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment86
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01616277A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy SubjectsPHASE1 COMPLETED 86 — — Jun 1, 2012Aug 1, 2014Sep 25, 20141 United States
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Study Endpoints
Primary Endpoints
Incidence of treatment related Adverse Events.
Day 197
Severity of treatment related Adverse Events.
Day 197
Incidence of abnormal lab findings.
Day 197
Magnitude of abnormal lab findings.
Day 197
Abnormal and clinically relevant changes in Blood Pressure.
Day 197
Abnormal and clinically relevant changes in Pulse Rate.
Day 197
Abnormal and clinically relevant changes in Respiratory Rate.
Day 197
Abnormal and clinically relevant changes in temperature.
Day 197
Abnormal and clinically relevant changes in ECG parameters.
Day 197
Secondary Endpoints
PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration)
Through Day 197 post dosing
Pharmacodynamic activity as measured by serum concentrations of GDF-8 (myostatin) as measured by a GDF-8 assay
Through Day 197 post dosing
Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay
Through Day 197 post dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1PLACEBO_COMPARATOR -
2PLACEBO_COMPARATOR -
3PLACEBO_COMPARATOR -
4PLACEBO_COMPARATOR -
5PLACEBO_COMPARATORRepeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram
6PLACEBO_COMPARATOR -
7PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PF-06252616BIOLOGICAL1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
PlaceboDRUGPlacebo for PF-06252616, IV infusion, single dose
PF-06252161BIOLOGICAL10.0 milligram per kilogram of PF-06252616, IV infusion, single dose
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Single Dose Cohorts-Healthy male and/or female non-child bearing subjects between the ages of 18 and 55 years, inclusive. * Repeat Dose Cohort-Healthy male and/or female non-child bearing subjects between the ages of 18 and less than 65 years, inclusive. Exclusion Criteria: ...

Countries:United States
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