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PF-04427429

Phase 1

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

PF-04427429 development status

Highest phase Phase 1
Registered trials 5 across 1 sponsor since Nov 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

PF-04427429 clinical trials

PF-04427429 · 1 trial · 2 indications

Phase 1 1
NCT01511497Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women VolunteersPain
COMPLETED31 Analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women Volunteers
PainUnlock trial analytics

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 to 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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Frequently asked questions about PF-04427429

What is PF-04427429?

PF-04427429 is an investigational monoclonal antibody developed by Pfizer for pain, including migraine disorders. It has been studied in a Phase 1 clinical trial in healthy women volunteers. It is not approved and remains in clinical development.

What is PF-04427429 used for?

PF-04427429 is being studied for the treatment of pain, with trial conditions including migraine disorders. The research is at an early stage, and the drug has not been approved for any use.

Who makes PF-04427429?

PF-04427429 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer conducted the Phase 1 study of the drug in the United States.

What phase is PF-04427429 in?

PF-04427429 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA.

What clinical trials is PF-04427429 in?

PF-04427429 has been evaluated in one completed Phase 1 trial, NCT01511497, titled a study of safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy women volunteers. The trial enrolled 31 participants in the United States and was randomized, double-blind, and placebo-controlled.