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PF-03526299

Phase 1

Asthma | Small molecule | Respiratory |Pfizer, Inc.|Last Updated: Sep 28, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

Clinical trial landscape

PF-03526299 · 2 trials · 2 indications

Phase 1 2
NCT00990756A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03526299 In Healthy Adult VolunteersHealthy
COMPLETED24 Analytics
NCT00877539A Study To Assess The Effect Of PF-03526299 On Lung Function Following An Allergen Challenge In Asthmatic SubjectsAsthma
COMPLETED29 Analytics
PHASE1COMPLETED
A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03526299 In Healthy Adult Volunteers
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study To Assess The Effect Of PF-03526299 On Lung Function Following An Allergen Challenge In Asthmatic Subjects
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.
17 days
Spirometry pre- and post- bronchial allergen challenge
2 months

Secondary Endpoints

Pharmacokinetic parameters: Plasma Day 1: Cmax, Tmax, AUCτau.
Day 1 - 17
Plasma Day 7: Cmax, Tmax.
7 Days
Plasma Day 14: Cmax, Tmax, CL/F, AUCτau, t½, accumulation ratio, time to steady state.
14 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-03526299 1.396 mgEXPERIMENTAL -
PF-03526299 4mgEXPERIMENTAL -
PF-03526299EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Fluticasone propionateACTIVE_COMPARATOR -

Interventions

NameTypeDescription
PF-03526299DRUGdry powder for inhalation, 1.396 mg, BID for 14 days
PlaceboDRUGInhaled, two doses 4 hours apart
Fluticasone propionateDRUGInhaled
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Eligibility Criteria

Age Range21 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects and females of non-childbearing potential between the ages of 21 and 55 years. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs). * Subjects who had a normal chest X-ray in the previous 6 months prior to Screening ...

Countries:SingaporeUnited Kingdom
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Frequently asked questions about PF-03526299

What is PF-03526299 used for?

PF-03526299 is an investigational small molecule being studied for respiratory conditions, specifically asthma. It was evaluated in a Phase 1 trial in asthmatic subjects to assess its effect on lung function following an allergen challenge. It has also been studied in healthy volunteers for safety and tolerability.

Who makes PF-03526299?

PF-03526299 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is in Phase 1 clinical development.

What phase is PF-03526299 in?

PF-03526299 is in Phase 1 clinical development. It has completed two Phase 1 trials, one in asthmatic subjects and one in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is PF-03526299 in?

PF-03526299 has completed two Phase 1 trials. NCT00877539 assessed its effect on lung function after an allergen challenge in 29 asthmatic subjects in the United Kingdom. NCT00990756 evaluated safety and tolerability of different doses in 24 healthy adult volunteers in Singapore.

Is PF-03526299 the same as another drug?

No alternative names for PF-03526299 have been disclosed. The drug is identified solely by its Pfizer development code, PF-03526299, in clinical trial registries and available information.