- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05496738
A Preliminary Study to Evaluate PF-07264660 in Healthy Participants
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, DOSE-ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE AND MULTIPLE INTRAVENOUS AND SUBCUTANEOUS DOSES OF PF-07264660 IN HEALTHY PARTICIPANTS
Study Overview
Status
Conditions
Detailed Description
This is an first-in-human within-cohort randomized, participant- and investigator-blind, sponsor-open, placebo-controlled study of the safety, tolerability, pharmacokinetics, and pharmacodynamics following single ascending dose and multiple ascending dose.
PF-07264660 that will be conducted in healthy adults. Up to approximately 67 participants will be enrolled into the study and randomly assigned to receive PF-07264660 or placebo. This will include up to approximately 43 healthy participants (including 5 optional Japanese participants) in Part A, and up to approximately 24 healthy participants (including 8 participants in optional multiple ascending dose cohort) in Part B.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Pfizer CT.gov Call Center
- Phone Number: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Locations
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-
California
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Garden Grove, California, United States, 92845
- Collaborative Neuroscience Research, LLC
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Long Beach, California, United States, 90806
- Collaborative Neuroscience Research, LLC
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Los Alamitos, California, United States, 90720
- Collaborative Neuroscience Research, LLC
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Minnesota
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Saint Paul, Minnesota, United States, 55114
- Prism Research LLC dba Nucleus Network
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Texas
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San Antonio, Texas, United States, 78229
- Clinical Trials of Texas, LLC
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Wisconsin
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West Bend, Wisconsin, United States, 53095
- Spaulding Clinical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
- Participants with acute or chronic infections or infection history
- History of human immunodeficiency virus (HIV); Infection with hepatitis B or hepatitis C viruses according to protocol specific testing algorithm
- History of febrile illness within 5 days prior to the first dose of investigational product.
- Recent exposure to live or attenuated vaccines within 28 days of the screening visit.
- Failure to comply with coronavirus disease 2019 (COVID-19) vaccination requirements as per site protocols.
- Have any malignancies or have a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
- History of any lymphoproliferative disorder such as Epstein-Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid tissue disease.
- Undergone significant trauma or major surgery within 1 month of the first dose of study drug
- Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
- Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥1.5 × Upper limit of normal (ULN);
- Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ULN.
- estimated glomerular filtration rate (eGFR) ≤75 mL/min/1.73 m2 based on chronic kidney disease epidemiology (CKD-EPI) equation
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening
- Participants with more than 5 cigarettes per day or ≥10 pack years
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PF-07264660 intravenous single ascending dose
PF-07264660 will be administered intravenously
|
PF-07264660 will be administered intravenously in single ascending doses
|
Experimental: PF-07264660 subcutaneous multiple ascending dose
PF-07264660 will be administered subcutaneously
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PF-07264660 will be administered subcutaneously in multiple ascending doses
|
Placebo Comparator: Intravenous placebo
Placebo will be administered intravenously
|
Placebo will be administered intravenously in single ascending doses
|
Placebo Comparator: Subcutaneous Placebo
Placebo will be administered subcutaneously
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Placebo will be administered subcutaneously in multiple ascending doses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment emergent treatment related adverse events (AE's)
Time Frame: Baseline up to approximately 1.5 years
|
To evaluate the safety and tolerability of PF 07264660, following single and multiple doses in healthy adults
|
Baseline up to approximately 1.5 years
|
Number of participants with treatment emergent treatment-related serious adverse events (SAE's)
Time Frame: Baseline up to approximately 1.5 years
|
To evaluate the safety and tolerability of PF 07264660, following single and multiple doses in healthy adults
|
Baseline up to approximately 1.5 years
|
Number of participants with change from baseline in blood pressure
Time Frame: 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
|
Baseline up to approximately 1.5 years
|
Number of participants with change from baseline in pulse rate
Time Frame: 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
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Baseline up to approximately 1.5 years
|
Number of participants with change from baseline in temperature
Time Frame: 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
|
Baseline up to approximately 1.5 years
|
Number of participants with change from baseline in clinical laboratory values
Time Frame: Baseline up to approximately 1.5 years
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Identify laboratory abnormalities from baseline will be summarized
|
Baseline up to approximately 1.5 years
|
Number of participants with change from baseline in heart rate
Time Frame: 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
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Baseline up to approximately 1.5 years
|
Number of participants with change from baseline in QT interval
Time Frame: 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
|
Baseline up to approximately 1.5 years
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Number of participants with change from baseline in corrected QT interval
Time Frame: 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
|
Baseline up to approximately 1.5 years
|
Number of participants with change from baseline in PR interval
Time Frame: 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
|
Baseline up to approximately 1.5 years
|
Number of participants with change from baseline in QRS interval
Time Frame: 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
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Baseline up to approximately 1.5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Baseline up to approximately 1.5 years
|
AUC of PF 07264660 will be calculated at selected timepoints
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Baseline up to approximately 1.5 years
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Number of participants with change from baseline in maximum plasma concentration (Cmax) of PF-07264660 after a single dose
Time Frame: Baseline up to approximately 1.5 years
|
Peak concentration of PF-07264660 during selected timepoints
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Baseline up to approximately 1.5 years
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Number of participants with change from baseline in maximum plasma concentration (Cmax) of PF-07264660 after multiple doses
Time Frame: Baseline up to approximately 1.5 years
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Peak concentration of PF-07264660 during selected timepoints
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Baseline up to approximately 1.5 years
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Number of participants with change from baseline in time to maximum plasma concentration (Tmax) of PF-07264660 after a single dose
Time Frame: Baseline up to approximately 1.5 years
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Time to peak concentration of PF-07264660 during selected timepoints
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Baseline up to approximately 1.5 years
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Number of participants with change from baseline in time to maximum plasma concentration (Tmax) of PF-07264660 after multiple doses
Time Frame: Baseline up to approximately 1.5 years
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Time to peak concentration of PF-07264660 during selected timepoints
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Baseline up to approximately 1.5 years
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Number of participants with change from baseline in terminal elimination half-life (t½) of PF-07264660 after a single dose
Time Frame: Baseline up to approximately 1.5 years
|
Terminal elimination half-life of PF-07264660 during selected timepoints
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Baseline up to approximately 1.5 years
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Number of participants with change from baseline in terminal elimination half-life (t½) of PF-07264660 after multiple doses
Time Frame: Baseline up to approximately 1.5 years
|
Terminal elimination half-life of PF-07264660 during selected timepoints
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Baseline up to approximately 1.5 years
|
Number of participants with change from baseline in area under the serum concentration time profile from time 0 extrapolated to infinite time (AUCinf) of single ascending doses of PF-07264660
Time Frame: Baseline up to approximately 1.5 years
|
AUC of PF 07264660 will be calculated at selected timepoints
|
Baseline up to approximately 1.5 years
|
Number of participants with change from baseline in area under the concentration time profile from time zero to time tau (τ), the dosing interval (AUCtau) of multiple ascending doses of PF-07264660
Time Frame: Baseline up to approximately 1.5 years
|
AUC of PF 07264660 will be calculated at selected timepoints
|
Baseline up to approximately 1.5 years
|
Number of participants with change from baseline in incidence and titers of anti-drug antibodies against PF-07264660
Time Frame: Baseline up to approximately 1.5 years
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Number of participants with the presence of anti-PF-07264660 antibodies
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Baseline up to approximately 1.5 years
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Number of participants with change from baseline in incidence and titers of neutralizing antibodies against PF-07264660
Time Frame: Baseline up to approximately 1.5 years
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Number of participants with the presence of anti-PF-07264660 antibodies
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Baseline up to approximately 1.5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- C4521001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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