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PF-04427429

Phase 1

Pain | Monoclonal antibody | Neurology |Pfizer, Inc.|Last Updated: Feb 21, 2013

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 Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01511497Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women VolunteersPHASE1 COMPLETED 31 — — Oct 1, 2011Jan 1, 2013Feb 21, 20133 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Screening up to Day 168
Incidence and severity of clinical laboratory abnormalities.
Screening up to Day 168
Mean change from baseline and placebo in blood pressure (BP).
Screening up to Day 168
Mean change from baseline in 12-lead electrocardiogram (ECG) parameters compared to baseline and placebo.
Screening up to Day 168
Categorical summary of QTcF compared to baseline between dose groups and placebo.
Screening up to Day 168
Anti-Drug Antibodies (ADA) responses.
From Day 0 up to Day 168 and until levels return to baseline.
Intravenous (IV) injection site reactions.
Day 1 post dose
Mean change from baseline and placebo in pulse rate (PR).
Screening up to Day 168
Mean change from baseline and placebo in body temperature.
Screening up to Day 168
Secondary Endpoints
Area under the concentration-time curve from zero to infinite time postdose (AUCinf).
Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Time to maximum concentration (Tmax).
Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Maximum concentration (Cmax).
Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-04427429EXPERIMENTAL -
PlaceboPLACEBO_COMPARATORNormal saline
Interventions
NameTypeDescription
PF-04427429BIOLOGICALIntravenous, single dose given over 1 hour with experimental dose. Subjects can receive one of four potential doses - 300, 1000, 1500 or 2000 mg.
Normal salineOTHERIntravenous, normal saline
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Eligibility Criteria
Age Range18 Years — 65 Years
SexFEMALE
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Generally healthy women, of non-child bearing potential, between the ages of 18 and 65 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate meas...

Countries:United States
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