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PF-07999415

Phase 1

Healthy | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Mar 20, 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_CONTROLLED
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06965465A Study to Learn How Different Amounts of the Study Medicine Called PF-07999415 Are Tolerated and Act in the Body in Healthy AdultsPHASE1 ACTIVE NOT_RECRUITING 32 — — Jun 20, 2025Aug 22, 2026Mar 20, 20261 Belgium
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Study Endpoints
Primary Endpoints
Number of participants with treatment emergent adverse events.
First dose (Day 1) to up to final follow-up visit (Day 85)
Secondary Endpoints
Area under the concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) for PF-07999415
First dose (Day 1) to up to final follow-up visit (Day 85)
Maximum observed concentration (Cmax) for PF-07999415
First dose (Day 1) to up to final follow-up visit (Day 85)
Time to maximum observed concentration (Tmax) for PF-07999415
First dose (Day 1) to up to final follow-up visit (Day 85)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-07999415EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PF-07999415BIOLOGICALParticipants will receive single doses of PF-07999415.
PlaceboDRUGParticipants will receive matching placebo.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female participants of non-childbearing potential aged 18 to 65 years, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Body Mass Index (BMI...

Countries:Belgium
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06965465primaryCompletionDate: changed
LOWMay 24, 2026NCT06965465studyFirstPostDate: changed