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PF-08065010

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

PF-08065010 · 1 trial · 1 indication

Phase 1 1
NCT07235163A Study to Learn How Different Amounts of the Study Medicine Called PF-08065010 Are Tolerated and Act in the Body of Healthy AdultsHealthy
RECRUITING100 Analytics
PHASE1RECRUITING
A Study to Learn How Different Amounts of the Study Medicine Called PF-08065010 Are Tolerated and Act in the Body of Healthy Adults
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline, approximately up to 5 months

Part A

Number of Participants With Clinically Significant Laboratory Abnormalities
Baseline, approximately up to 5 months

Part A

Number of Participants With Vital Sign Abnormalities
Baseline, approximately up to 5 months

Part A

Number of Participants with Change from Baseline in Physical Exam (PE) Parameters
Baseline, approximately up to 5 months

Part A

Number of Participants with Change from Baseline in Electrocardiogram (ECG) Parameters
Baseline, approximately up to 5 months

Part A

Secondary Endpoints

Area Under the Plasma Concentration-time Profile from Time Zero to the Time of Last Quantifiable Concentration (AUClast)
Predose (Day 1), approximately up to 5 months
Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf)
Predose (Day 1), approximately up to 5 months
Maximum Observed Plasma Concentration (Cmax)
Predose (Day 1), approximately up to 5 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part A: Cohort 3: single ascending dose (SAD)EXPERIMENTALDose C - Participants will receive PF-08065010 or placebo.
Part A: Cohort 8: single ascending dose (SAD)EXPERIMENTALOptional Japanese Cohort dose to be determined - Participants will receive PF-08065010 or placebo.
Part A: Cohort 1: single ascending dose (SAD)EXPERIMENTALDose A - Participants will receive PF-08065010 or placebo.
Part A: Cohort 5: single ascending dose (SAD)EXPERIMENTALDose E - Participants will receive PF-08065010 or placebo.
Part A: Cohort 7: single ascending dose (SAD)EXPERIMENTALDose G - Participants will receive PF-08065010 or placebo.
Part A: Cohort 4: single ascending dose (SAD)EXPERIMENTALDose D - Participants will receive PF-08065010 or placebo.
Part A: Cohort 2: single ascending dose (SAD)EXPERIMENTALDose B - Participants will receive PF-08065010 or placebo.
Part A: Cohort 9: single ascending dose (SAD)EXPERIMENTALOptional Chinese Cohort dose to be determined - Participants will receive PF-08065010 or placebo.
Part A: Cohort 6: single ascending dose (SAD)EXPERIMENTALDose F - Participants will receive PF-08065010 or placebo.
Part A: Cohort 10: single ascending dose (SAD)EXPERIMENTALOptional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo.
Part A: Cohort 11: single ascending dose (SAD)EXPERIMENTALOptional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo.
Part B: Cohort 12: multiple doseEXPERIMENTALDose F - Participants will receive PF-08065010 or placebo.
Part B: Cohort 13: multiple doseEXPERIMENTALOptional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo.
Part B: Cohort 14: multiple doseEXPERIMENTALOptional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo.

Interventions

NameTypeDescription
PF-08065010DRUGExperimental Pfizer compound which will be subcutaneous (SC) or intravenous (IV).
PlaceboDRUGPlacebo which will be SC or IV
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * male or female between 18 and 65 years of age * deemed to be healthy Exclusion Criteria: 1. Evidence or history of clinically significant medical conditions. 2. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, he...

Countries:Belgium
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Recent Changes (Last 90 Days)

LOWAug 24, 2026NCT07235163Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 24, 2026NCT07235163Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about PF-08065010

What is PF-08065010 used for?

PF-08065010 is an investigational small molecule being studied in healthy adults. It is currently in a Phase 1 clinical trial to evaluate how different amounts of the study medicine are tolerated and how it acts in the body. The drug is not approved and remains in clinical development.

Who makes PF-08065010?

PF-08065010 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 a Phase 1 clinical trial to study the drug in healthy adult volunteers.

What phase is PF-08065010 in?

PF-08065010 is in Phase 1 clinical development. The drug is being studied in a single active trial that is currently recruiting participants. It is an investigational medicine and has not been approved for any use.

What clinical trials is PF-08065010 in?

PF-08065010 is being studied in one Phase 1 clinical trial with the identifier NCT07235163. The trial is recruiting healthy adults aged 18 years and older in Belgium, with an enrollment target of 100 participants. The study is randomized, double-blind, and controlled.

How does PF-08065010 work?

PF-08065010 is a small molecule, but its specific molecular target has not been disclosed. The ongoing Phase 1 trial is designed to assess how different doses of the drug are tolerated and how it behaves in the body of healthy adults.