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PF-07264660 single ascending dose

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jun 6, 2024

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 Enrollment59
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05496738A Preliminary Study to Evaluate PF-07264660 in Healthy ParticipantsPHASE1 COMPLETED 59 — — Aug 16, 2022May 6, 2024Jun 6, 20246 United States
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Study Endpoints
Primary Endpoints
Number of participants with treatment emergent treatment related adverse events (AE's)
Baseline up to approximately 1.5 years

To evaluate the safety and tolerability of PF 07264660, following single and multiple doses in healthy adults

Number of participants with treatment emergent treatment-related serious adverse events (SAE's)
Baseline up to approximately 1.5 years

To evaluate the safety and tolerability of PF 07264660, following single and multiple doses in healthy adults

Number of participants with change from baseline in blood pressure
Baseline up to approximately 1.5 years

Identify systolic and diastolic readings that are outside the normal range. The number and percentage of participants who experienced significant blood pressure change from baseline will be summarized

Number of participants with change from baseline in pulse rate
Baseline up to approximately 1.5 years

Identify pulse rate readings that are outside the normal range. The number and percentage of participants who experienced significant pulse rate change from baseline will be summarized

Number of participants with change from baseline in temperature
Baseline up to approximately 1.5 years

Identify temperature readings that are outside the normal range. The number and percentage of participants who experienced significant temperature change from baseline will be summarized

Number of participants with change from baseline in clinical laboratory values
Baseline up to approximately 1.5 years

Identify laboratory abnormalities from baseline will be summarized

Number of participants with change from baseline in heart rate
Baseline up to approximately 1.5 years

Determine the effect of the drug on heart rate The number and percentage of participants who experienced heart rate changes will be summarized

Number of participants with change from baseline in QT interval
Baseline up to approximately 1.5 years

Determine the effect of the drug on QT interval. The number and percentage of participants who experienced QT interval changes will be summarized

Number of participants with change from baseline in corrected QT interval
Baseline up to approximately 1.5 years

Determine the effect of the drug on corrected QT interval. The number and percentage of participants who experienced corrected QT interval changes will be summarized

Number of participants with change from baseline in PR interval
Baseline up to approximately 1.5 years

Determine the effect of the drug on PR interval. The number and percentage of participants who experienced PR interval changes will be summarized

Number of participants with change from baseline in QRS interval
Baseline up to approximately 1.5 years

Determine the effect of the drug on QRS interval. The number and percentage of participants who experienced QRS interval changes will be summarized

Secondary Endpoints
Number of participants with change from baseline in area under the concentration versus time curve from time zero to the last quantifiable time point (AUClast) of single ascending doses of PF-07264660
Baseline up to approximately 1.5 years
Number of participants with change from baseline in maximum plasma concentration (Cmax) of PF-07264660 after a single dose
Baseline up to approximately 1.5 years
Number of participants with change from baseline in maximum plasma concentration (Cmax) of PF-07264660 after multiple doses
Baseline up to approximately 1.5 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-07264660 intravenous single ascending doseEXPERIMENTALPF-07264660 will be administered intravenously
PF-07264660 subcutaneous multiple ascending doseEXPERIMENTALPF-07264660 will be administered subcutaneously
Intravenous placeboPLACEBO_COMPARATORPlacebo will be administered intravenously
Subcutaneous PlaceboPLACEBO_COMPARATORPlacebo will be administered subcutaneously
Interventions
NameTypeDescription
PF-07264660 intravenous single ascending doseDRUGPF-07264660 will be administered intravenously in single ascending doses
PF-07264660 subcutaneous multiple ascending doseDRUGPF-07264660 will be administered subcutaneously in multiple ascending doses
Intravenous placeboOTHERPlacebo will be administered intravenously in single ascending doses
subcutaneous placeboOTHERPlacebo will be administered subcutaneously in multiple ascending doses
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: * Healthy volunteer male and female participants between 18 to 65 years of age * Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight \>50 kg (110 lb) Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, ...

Countries:United States
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