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PF-07999415

Phase 1

Healthy | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Jul 23, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

PF-07999415 · 1 trial · 1 indication

Phase 1 1
NCT06965465A Study to Learn How Different Amounts of the Study Medicine Called PF-07999415 Are Tolerated and Act in the Body in Healthy AdultsHealthy
ACTIVE NOT_RECRUITING32 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Learn How Different Amounts of the Study Medicine Called PF-07999415 Are Tolerated and Act in the Body in Healthy Adults
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with treatment emergent adverse events.
First dose (Day 1) to up to final follow-up visit (Day 120)

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 120)
Maximum observed concentration (Cmax) for PF-07999415
First dose (Day 1) to up to final follow-up visit (Day 120)
Time to maximum observed concentration (Tmax) for PF-07999415
First dose (Day 1) to up to final follow-up visit (Day 120)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
PF-07999415EXPERIMENTAL -

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 to 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)

LOWJul 24, 2026NCT06965465enrollmentType: changed
LOWJul 24, 2026NCT06965465enrollmentType: changed

Frequently asked questions about PF-07999415

What is PF-07999415?

PF-07999415 is an investigational monoclonal antibody being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development for use in healthy adults. The drug is being studied to understand how different amounts are tolerated and how they act in the body.

What is PF-07999415 used for?

PF-07999415 is being studied in healthy adults as part of a Phase 1 clinical trial. The trial aims to evaluate how different doses of the study medicine are tolerated and how they behave in the body. It is not yet approved for any medical condition.

Who makes PF-07999415?

PF-07999415 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 evaluate the drug's safety and pharmacokinetics in healthy adults.

What phase is PF-07999415 in?

PF-07999415 is in Phase 1 clinical development. The ongoing trial is a randomized, double-blind, placebo-controlled study in healthy adults. The trial is active but not recruiting participants, and it is being conducted in Belgium.

What clinical trials is PF-07999415 in?

PF-07999415 is being studied in a Phase 1 clinical trial with the identifier NCT06965465. The trial is titled 'A Study to Learn How Different Amounts of the Study Medicine Called PF-07999415 Are Tolerated and Act in the Body in Healthy Adults.' It enrolls 32 healthy adult participants and is active but not recruiting.

Is PF-07999415 FDA approved?

PF-07999415 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing trial is evaluating the drug's tolerability and pharmacokinetics in healthy adults, and it has not yet progressed to later-stage trials or regulatory approval.