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PF-08065010

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 19, 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-BlindCONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07235163A Study to Learn How Different Amounts of the Study Medicine Called PF-08065010 Are Tolerated and Act in the Body of Healthy AdultsPHASE1 NOT YET_RECRUITING 100Apr 13, 2026Jul 16, 2027Mar 19, 2026 -
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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 1: single ascending dose (SAD)EXPERIMENTALDose A - 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 3: single ascending dose (SAD)EXPERIMENTALDose C - 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 5: single ascending dose (SAD)EXPERIMENTALDose E - 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 7: single ascending dose (SAD)EXPERIMENTALDose G - 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 9: single ascending dose (SAD)EXPERIMENTALOptional Chinese Cohort dose to be determined - 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 — 65 Years
SexALL
Healthy VolunteersYes

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...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07235163primaryCompletionDate: changed
LOWMay 24, 2026NCT07235163studyFirstPostDate: changed