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PF-04427429

Phase 1

Healthy | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Dec 4, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials3
Total Enrollment73

FDA Designations

No designations recorded

Clinical trial landscape

PF-04427429 · 5 trials · 4 indications

Phase 1 5
NCT01511497Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women VolunteersPain
COMPLETED31 Analytics
NCT01147432Acute Response Capsaicin Flare StudyHealthy
COMPLETED12 Analytics
NCT01165723A Clinical Study Evaluating The Safety And Tolerability Of PF-04427429 In Healthy Adult Volunteers. The Pharmacokinetics And Pharmacodynamics Of PF-04427429 Will Also Be InvestigatedHealthy
COMPLETED21 Analytics
NCT01117233Study In Healthy Adult Volunteers To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429Healthy
COMPLETED40 Analytics
NCT01011296First In Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult VolunteersHealthy Volunteers
COMPLETED24 Analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women Volunteers
Pain
NCT0151149731
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PHASE1COMPLETED
Acute Response Capsaicin Flare Study
Healthy
NCT0114743212
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PHASE1COMPLETED
A Clinical Study Evaluating The Safety And Tolerability Of PF-04427429 In Healthy Adult Volunteers. The Pharmacokinetics And Pharmacodynamics Of PF-04427429 Will Also Be Investigated
Healthy
NCT0116572321
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PHASE1COMPLETED
Study In Healthy Adult Volunteers To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429
Healthy
NCT0111723340
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PHASE1COMPLETED
First In Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers
Healthy Volunteers
NCT0101129624
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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
Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin
7 weeks post first dose
Safety (incidence/severity of adverse events and clinical laboratory abnormalities, mean change from baseline/placebo in vital signs/body temperature, mean change from baseline in 12 lead electrocardiogram parameters compared to baseline/placebo)
up to 129 days
Safety continued (categorical summary of QTcF compared to baseline between dose groups and placebo, concentration QTcF relationship, ADA responses, IV injection site reactions
up to 129 days
Pharmacokinetics (free plasma concentrations of PF-04427429 will be measured by a validated assay and non-compartmental PK parameters will be determined for each dose)
up to 129 days
Adverse events, Vitals, ECG, laboratory safety tests, IV infusion site reaction
up to 84 days
Plasma pharmacokinetics of PF-04427429
up to 84 days
Safety (incidence/severity of adverse events and clinical laboratory abnormalities, mean change from baseline/placebo in vital signs/body temperature, mean change from baseline in 12 lead electrocardiogram parameters compared to baseline/ placebo)
anticipated time is up to 84 days post dose
Safety continued (categorical summary of QTcF compared to baseline between dose groups and placebo, concentration QTcF relationship, ADA responses, IV injection site reactions)
anticipated time is up to 84 days post dose to 84 days

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
EMLAACTIVE_COMPARATOR -
IV Dose 1: experimentalEXPERIMENTAL -
IV Dose 2: experimentalEXPERIMENTAL -
Single IV Dose 1EXPERIMENTAL -
Single IV Dose 2EXPERIMENTAL -
Single IV Dose 3EXPERIMENTAL -
Single IV Dose 4EXPERIMENTAL -
Single IV Dose 5EXPERIMENTAL -

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
Capsaicin challengeOTHERCapsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period
PlaceboDRUGPlacebo IV infusion (saline) to be administered during two of the three treatment periods
EMLA positive controlOTHER2g EMLA cream to be applied ONCE during study period 1
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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 StatesBelgium
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Frequently asked questions about PF-04427429

What is PF-04427429 used for?

PF-04427429 is an investigational monoclonal antibody being studied in healthy volunteers and in women with pain and migraine disorders. It is in Phase 1 clinical development and is not approved for any use. All completed trials have focused on safety, tolerability, pharmacokinetics, and pharmacodynamics.

Who makes PF-04427429?

PF-04427429 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company has sponsored multiple Phase 1 clinical trials of the drug in healthy volunteers and in women with pain and migraine disorders.

What phase is PF-04427429 in?

PF-04427429 is in Phase 1 clinical development. All three completed trials were Phase 1 studies. The drug is investigational and has not been approved by regulatory authorities. No active trials are currently listed for PF-04427429.

What clinical trials is PF-04427429 in?

PF-04427429 has been studied in three completed Phase 1 trials. NCT01011296 and NCT01117233 evaluated safety and tolerability in healthy volunteers. NCT01511497 studied the drug in healthy women with pain and migraine disorders. All trials were completed.

Is PF-04427429 the same as any other drug?

PF-04427429 is the only name provided for this drug. It is a monoclonal antibody developed by Pfizer. No alternative names have been reported for this investigational agent.