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PF-07209326

Phase 1

Healthy | Monoclonal antibody | Hematology |Pfizer, Inc.|Last Updated: Dec 18, 2023

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04255875Dose Escalation Study of PF-07209326 in Healthy Participants and Participants With Sickle Cell DiseasePHASE1 COMPLETED 52 — — Feb 5, 2020Jul 7, 2023Dec 18, 202316 United States
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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 — 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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