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PF-08057418

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 24, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

PF-08057418 · 1 trial · 1 indication

Phase 1 1
NCT07575906A Study to Learn How a Single Dose of the Study Medicine Called PF-08057418 is Tolerated in the Body of Healthy Adults.Healthy
COMPLETED8 Analytics
PHASE1COMPLETED
A Study to Learn How a Single Dose of the Study Medicine Called PF-08057418 is Tolerated in the Body of Healthy Adults.
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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
PlaceboPLACEBO_COMPARATORParticipants will receive single oral solution or tablet dose(s) of placebo.
PF-08057418EXPERIMENTALParticipants will receive single oral solution or tablet dose(s) of PF-08057418

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 to 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)

MEDIUMAug 24, 2026NCT07575906TRIAL_REMOVED: changed
MEDIUMAug 24, 2026NCT07575906TRIAL_REMOVED: changed
MEDIUMAug 24, 2026NCT07575906TRIAL_REMOVED: changed
HIGHJul 24, 2026NCT07575906Status: RECRUITING → COMPLETED
HIGHJul 24, 2026NCT07575906Status: RECRUITING → COMPLETED

Frequently asked questions about PF-08057418

What is PF-08057418 used for?

PF-08057418 is an investigational small molecule being studied for use in healthy adults. It is currently in Phase 1 clinical development, with a completed trial evaluating how a single dose is tolerated in the body. It is not approved for any condition and remains under investigation.

Who makes PF-08057418?

PF-08057418 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational small molecule in healthy adult participants.

What phase is PF-08057418 in?

PF-08057418 is in Phase 1 clinical development. A Phase 1 trial has been completed, which studied how a single dose of the medicine is tolerated in healthy adults. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is PF-08057418 in?

PF-08057418 has one completed Phase 1 clinical trial registered as NCT07575906. The study, titled "A Study to Learn How a Single Dose of the Study Medicine Called PF-08057418 is Tolerated in the Body of Healthy Adults," enrolled 8 participants in the United States. It was a randomized, double-blind, placebo-controlled trial.

Is PF-08057418 FDA approved?

PF-08057418 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A Phase 1 trial has been completed to evaluate its tolerability in healthy adults, but the drug has not received regulatory approval for any use.