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PF-07209326

Phase 1

Sickle Cell Anemia | Monoclonal antibody | Hematology |Pfizer, Inc.|Trials Updated: Jun 15, 2026

PF-07209326 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2020

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

PF-07209326 clinical trials

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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Frequently asked questions about PF-07209326

What is PF-07209326?

PF-07209326 is an investigational monoclonal antibody developed by Pfizer, Inc. (NYSE: PFE) for sickle cell anemia, a hematologic disorder. It is in Phase 1 clinical development and has been studied in a single completed trial. It is not yet approved for any indication.

What is PF-07209326 used for in sickle cell anemia?

PF-07209326 is being developed as a potential treatment for sickle cell anemia. It has been evaluated in a Phase 1 dose escalation study that enrolled healthy participants and participants with sickle cell disease. The drug remains investigational and is not approved for use in sickle cell anemia or any other condition.

Who makes PF-07209326?

PF-07209326 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical program evaluating this monoclonal antibody in sickle cell anemia and in healthy volunteers.

What phase is PF-07209326 in?

PF-07209326 is in Phase 1 clinical development. The only listed trial is a completed Phase 1 dose escalation study. The drug is investigational and has not received FDA approval for any indication.

What clinical trials is PF-07209326 in?

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