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SRA-444

Phase 1

Alzheimer Disease | Small molecule | Neurology |Pfizer, Inc.|Trials Updated: Jul 9, 2008

SRA-444 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Mar 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment106

FDA Designations

No designations recorded

SRA-444 clinical trials

SRA-444 · 2 trials · 2 indications

Phase 1 2
NCT00499200Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor OccupancyAlzheimer's Disease
COMPLETED42 Analytics
NCT00452504Single Ascending Dose Study of SRA-444 in Healthy SubjectsAlzheimer Disease
COMPLETED64 Analytics
PHASE1COMPLETED
Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy
Alzheimer's DiseaseUnlock trial analytics
PHASE1COMPLETED
Single Ascending Dose Study of SRA-444 in Healthy Subjects
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the safety and tolerability of ascending single oral doses of SRA-444 in healthy elderly subjects and subjects with Alzheimer's disease
after each dose group completion
To obtain PK profiles and determine the level and duration of 5-HT1A RO of SRA-444 by PET
1 month
Assessment of the safety and tolerability of SRA-444
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SRA-444 + PlaceboEXPERIMENTALExperimental; Placebo

Interventions

NameTypeDescription
SRA-444DRUG -
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Eligibility Criteria

Age Range60 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Men or women from 60 years of age at screening. * Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG). Exclusion criteria: * History of drug abuse ...

Countries:SwedenNetherlands
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Frequently asked questions about SRA-444

What is SRA-444?

SRA-444 is an investigational small molecule being developed by Pfizer, Inc. (PFE) for Alzheimer disease. It is in Phase 1 clinical development and has been studied in two completed Phase 1 trials with a combined enrollment of 106 participants. SRA-444 has not been approved for any indication.

What is SRA-444 used for in Alzheimer disease?

SRA-444 is being studied as a potential treatment for Alzheimer disease. It is an investigational small molecule in Phase 1 development, and its safety, tolerability, and pharmacokinetics have been evaluated in two completed Phase 1 trials. It is not approved for Alzheimer disease or any other indication.

Who makes SRA-444?

SRA-444 is being developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor of the Phase 1 clinical trials evaluating SRA-444 in Alzheimer disease.

What phase is SRA-444 in?

SRA-444 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and there are currently no active trials. SRA-444 is investigational and has not been approved by the FDA or any other regulatory agency.

What clinical trials is SRA-444 in?

SRA-444 has been evaluated in two completed Phase 1 trials: NCT00499200, which studied safety, tolerability, pharmacokinetics, and 5 HT1A receptor occupancy in 42 participants in Sweden, and NCT00452504, a single ascending dose study in 64 healthy subjects in the Netherlands. Both trials are completed.