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PF-07985631

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 20, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment92

FDA Designations

No designations recorded

Clinical trial landscape

PF-07985631 · 1 trial · 1 indication

Phase 1 1
NCT06994897A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy AdultsHealthy
RECRUITING92 Analytics
PHASE1RECRUITING
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 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 (TEAEs) and Serious Adverse Events (SAE)
Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)
Number of Participants With Notable Electrocardiogram (ECG) Values
Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)
Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)

Secondary Endpoints

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): MD cohorts only
Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf): SAD cohorts only
Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): SAD cohorts only
Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cohort 1: single ascending doseEXPERIMENTALDose A (3 active: 2 placebo)
Cohort 2: single ascending doseEXPERIMENTALDose B (3 active: 2 placebo)
Cohort 3: single ascending doseEXPERIMENTALDose C (6 active: 2 placebo)
Cohort 4: single ascending doseEXPERIMENTALDose D (6 active: 2 placebo)
Cohort 5: single ascending doseEXPERIMENTALOptional Cohort with dose to be determined (6 active: 2 placebo)
Cohort 6: single ascending doseEXPERIMENTALOptional Cohort with dose to be determined (6 active: 2 placebo)
Cohort 7: single ascending doseEXPERIMENTALOptional Cohort with dose to be determined (6 active: 2 placebo)
Cohort 8: single doseEXPERIMENTALOptional Japanese Cohort dose to be determined (4 active: 1 placebo)
Cohort 9: single doseEXPERIMENTALOptional Chinese Cohort dose to be determined (4 active: 1 placebo)
Cohort 10: multiple doseEXPERIMENTALOptional Cohort with dose to be determined (6 active: 2 placebo)
Cohort 11EXPERIMENTALOptional Cohort with dose to be determined (6 active: 2 placebo)
Cohort 12EXPERIMENTALOptional Cohort with dose to be determined (6 active: 2 placebo)
Cohort 13EXPERIMENTALOptional Cohort with dose to be determined (6 active: 2 placebo)

Interventions

NameTypeDescription
PF-07985631DRUGExperimental Pfizer compound which will be SC or IV
PlaceboDRUGPlacebo which will be SC or IV
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion: 1. Between 18 and 45 years of age who are overtly healthy. 2. Japanese/Chinese and multiple dose cohorts only: Adult participants 18 to 55 years of age who are overtly healthy may be eligible at the discretion of PI. 3. Japanese/Chinese cohorts only: Participants must have 4 biological J...

Countries:Belgium
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Frequently asked questions about PF-07985631

What is PF-07985631 used for?

PF-07985631 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. It is not approved for any condition and remains in clinical development.

Who makes PF-07985631?

PF-07985631 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 of this investigational small molecule in healthy adult volunteers.

What phase is PF-07985631 in?

PF-07985631 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 study is recruiting participants to assess the tolerability and pharmacokinetics of different doses in healthy adults.

What clinical trials is PF-07985631 in?

PF-07985631 is being studied in one active Phase 1 clinical trial with the identifier NCT06994897. This randomized, double-blind, controlled study is recruiting 92 healthy adults in Belgium to evaluate how different amounts of the study medicine are tolerated and act in the body.

Is PF-07985631 FDA approved?

PF-07985631 is not FDA approved. It is an investigational small molecule currently in Phase 1 clinical development. The ongoing trial is designed to assess safety, tolerability, and how the drug behaves in the body of healthy adults, which is an early stage of the drug development process.