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PF-08057418

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: May 28, 2026

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 Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07575906A Study to Learn How a Single Dose of the Study Medicine Called PF-08057418 is Tolerated in the Body of Healthy Adults.PHASE1 RECRUITING 8May 8, 2026Jul 23, 2026May 28, 20261 United States
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Study Endpoints
Primary Endpoints
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Up to 10 weeks

Assessment of TEAEs, SAEs, clinical laboratory values, vital signs, continuous cardiac monitoring and 12-lead ECGs

Secondary Endpoints
Pharmacokinetics (PK): Area under the concentration-time curve (AUC) of PF-08057418
Up to 10 weeks
PK: Maximum Observed Plasma Concentration (Cmax) of PF-08057418
Up to 10 weeks
PK: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-08057418
Up to 10 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-08057418EXPERIMENTALParticipants will receive single oral solution or tablet dose(s) of PF-08057418
PlaceboPLACEBO_COMPARATORParticipants will receive single oral solution or tablet dose(s) of placebo.
Interventions
NameTypeDescription
PF-08057418DRUGsolution or tablet (fasted/fed)
Placebo (A placebo does not have any medicine in it but looks just like the medicine being studied.)OTHERsolution or tablet (fasted/fed)
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Adults 18 to 60 years of age (or the minimum age of consent per local regulations) at screening. * Healthy participants, as determined by medical history, physical examination, clinical laboratory tests, and cardiac monitoring. * Body mass index (BMI) between 16 and 32 kg/m² a...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07575906Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 29, 2026NCT07575906Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 29, 2026NCT07575906Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07575906studyFirstPostDate: changed
LOWMay 21, 2026NCT07575906NEW_TRIAL: changed
LOWMay 21, 2026NCT07575906NEW_TRIAL: changed