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PF-07209326

Phase 1

Healthy | Monoclonal antibody | Hematology |Pfizer, Inc.|Last Updated: Jun 15, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

PF-07209326 · 1 trial · 2 indications

Phase 1 1
NCT04255875Dose Escalation Study of PF-07209326 in Healthy Participants and Participants With Sickle Cell DiseaseHealthy
COMPLETED52 Analytics
PHASE1COMPLETED
Dose Escalation Study of PF-07209326 in Healthy Participants and Participants With Sickle Cell Disease
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Study Endpoints

Primary Endpoints

Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Day 1 up to Day 85 (SAD) or Day 113 (MD)
Percentage of subjects with laboratory abnormalities
Day 1 up to Day 85 (SAD) or Day 113 (MD)
Number of subjects with change from baseline in vital signs
Day 1 up to Day 85 (SAD) or Day 85 (MD)

blood pressure, pulse rate, temperature, respiration rate

Number of subjects with change from baseline in electrocardiogram (ECG) parameters
Day 1 up to Day 85 (SAD) or Day 85 (MD)
Percentage of subjects with injection site reactions
Day 1 up to Day 11 post (SAD) Day 1 up to Day 85 (MD)
Percentage of subjects with infusion site reactions
Day 1 up to Day 11 post each dose (SD)

Secondary Endpoints

SAD: Single Dose PK /Cmax
Day 1 up to Day 85
SAD: Single Dose PK / DN Cmax
Day 1 up to Day 85
SAD: Single Dose PK / Tmax
Day 1 up to Day 85
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Treatment Healthy ParticipantsEXPERIMENTALParticipants will receive single ascending doses of subcutaneous (SC) or intravenous PF-07209326
Placebo Healthy ParticipantsPLACEBO_COMPARATORParticipants will receive matching placebo
Treatment for SCDEXPERIMENTALParticipants will receive a multiple dose of subcutaneous PF-07209326

Interventions

NameTypeDescription
PlaceboBIOLOGICALParticipants will receive matching placebo
PF-07209326BIOLOGICALParticipants will receive SC or IV single ascending doses
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Eligibility Criteria

Age Range16 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites16

Inclusion Criteria Health Participants: 1\. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria Healthy Participants: 1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, immunocomprom...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMJul 16, 2026NCT04255875TRIAL_REMOVED: changed
MEDIUMJul 16, 2026NCT04255875TRIAL_REMOVED: changed
MEDIUMJul 16, 2026NCT04255875TRIAL_REMOVED: changed

Frequently asked questions about PF-07209326

What is PF-07209326?

PF-07209326 is an investigational monoclonal antibody being developed by Pfizer, Inc. (PFE) for use in hematology. It is currently in Phase 1 clinical development. The drug has been studied in healthy participants and in participants with sickle cell disease, though it is not yet approved for any indication.

What does PF-07209326 target?

PF-07209326 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being investigated for potential use in hematology, specifically in the context of sickle cell disease, based on a completed Phase 1 trial.

Who makes PF-07209326?

PF-07209326 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company conducted a Phase 1 clinical trial of the drug in healthy participants and participants with sickle cell disease.

What phase is PF-07209326 in?

PF-07209326 is in Phase 1 clinical development. It has completed a Phase 1 dose escalation study in healthy participants and participants with sickle cell disease. The drug is investigational and has not been approved by regulatory authorities for any use.

What clinical trials is PF-07209326 in?

PF-07209326 has been studied in one completed clinical trial, NCT04255875, titled "Dose Escalation Study of PF-07209326 in Healthy Participants and Participants With Sickle Cell Disease." This Phase 1 trial enrolled 52 participants in the United States and was placebo-controlled and double-blind.

Is PF-07209326 the same as any other drug?

No alternative names for PF-07209326 have been disclosed. The drug is known by its development code PF-07209326 and is being studied by Pfizer for potential use in hematology, including sickle cell disease.