A Preliminary Study to Evaluate PF-07264660 in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05496738
• Other study ID #: C4521001
• Status: Completed
• Phase: Phase 1
• Start date: August 16, 2022
• Est. completion date: May 6, 2024

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to learn about the safety and effects of study medicine PF-07264660 compared to a placebo. This is the first study of PF-07264660 in humans. All participants in this study will received PF-07264660 or a placebo and it will be assigned by chance. People may be able to participate if they are healthy. The study medicine may be given by shots under the skin or through a vein depending on which group you are assigned to. If you are assigned into Part A, you will receive the study medicine once, stay overnight at the research unit from 3 to 5 overnight stays and you will need to visit the clinic about 11 follow-up visits. Participants will be in this study for up to about 541 days. If you are assigned into Part B, you will receive the study medicine three times, stay overnight at the clinic from 3 to 5 overnight stays and you will need to visit the research unit about 12 follow-up visits. Participants willbe in this study for up to about 561 days.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 6, 2024
• Est. primary completion date: May 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-07264660 intravenous single ascending dose
PF-07264660 will be administered intravenously in single ascending doses
• PF-07264660 subcutaneous multiple ascending dose
PF-07264660 will be administered subcutaneously in multiple ascending doses

Other:
• Intravenous placebo
Placebo will be administered intravenously in single ascending doses
• subcutaneous placebo
Placebo will be administered subcutaneously in multiple ascending doses

Locations

Country	Name	City	State
United States	Collaborative Neuroscience Research, LLC	Garden Grove	California
United States	Collaborative Neuroscience Research, LLC	Long Beach	California
United States	Collaborative Neuroscience Research, LLC	Los Alamitos	California
United States	Prism Research LLC dba Nucleus Network	Saint Paul	Minnesota
United States	Clinical Trials of Texas, LLC	San Antonio	Texas
United States	Spaulding Clinical Research	West Bend	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment emergent treatment related adverse events (AE's)	To evaluate the safety and tolerability of PF 07264660, following single and multiple doses in healthy adults	Baseline up to approximately 1.5 years
Primary	Number of participants with treatment emergent treatment-related serious adverse events (SAE's)	To evaluate the safety and tolerability of PF 07264660, following single and multiple doses in healthy adults	Baseline up to approximately 1.5 years
Primary	Number of participants with change from baseline in blood pressure	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
Primary	Number of participants with change from baseline in pulse rate	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	Baseline up to approximately 1.5 years
Primary	Number of participants with change from baseline in temperature	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
Primary	Number of participants with change from baseline in clinical laboratory values	Identify laboratory abnormalities from baseline will be summarized	Baseline up to approximately 1.5 years
Primary	Number of participants with change from baseline in heart rate	Determine the effect of the drug on heart rate The number and percentage of participants who experienced heart rate changes will be summarized	Baseline up to approximately 1.5 years
Primary	Number of participants with change from baseline in QT interval	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
Primary	Number of participants with change from baseline in corrected QT interval	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
Primary	Number of participants with change from baseline in PR interval	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
Primary	Number of participants with change from baseline in QRS interval	Determine the effect of the drug on QRS interval. The number and percentage of participants who experienced QRS interval changes will be summarized	Baseline up to approximately 1.5 years
Secondary	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	AUC of PF 07264660 will be calculated at selected timepoints	Baseline up to approximately 1.5 years
Secondary	Number of participants with change from baseline in maximum plasma concentration (Cmax) of PF-07264660 after a single dose	Peak concentration of PF-07264660 during selected timepoints	Baseline up to approximately 1.5 years
Secondary	Number of participants with change from baseline in maximum plasma concentration (Cmax) of PF-07264660 after multiple doses	Peak concentration of PF-07264660 during selected timepoints	Baseline up to approximately 1.5 years
Secondary	Number of participants with change from baseline in time to maximum plasma concentration (Tmax) of PF-07264660 after a single dose	Time to peak concentration of PF-07264660 during selected timepoints	Baseline up to approximately 1.5 years
Secondary	Number of participants with change from baseline in time to maximum plasma concentration (Tmax) of PF-07264660 after multiple doses	Time to peak concentration of PF-07264660 during selected timepoints	Baseline up to approximately 1.5 years
Secondary	Number of participants with change from baseline in terminal elimination half-life (t½) of PF-07264660 after a single dose	Terminal elimination half-life of PF-07264660 during selected timepoints	Baseline up to approximately 1.5 years
Secondary	Number of participants with change from baseline in terminal elimination half-life (t½) of PF-07264660 after multiple doses	Terminal elimination half-life of PF-07264660 during selected timepoints	Baseline up to approximately 1.5 years
Secondary	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	AUC of PF 07264660 will be calculated at selected timepoints	Baseline up to approximately 1.5 years
Secondary	Number of participants with change from baseline in area under the concentration time profile from time zero to time tau (t), the dosing interval (AUCtau) of multiple ascending doses of PF-07264660	AUC of PF 07264660 will be calculated at selected timepoints	Baseline up to approximately 1.5 years
Secondary	Number of participants with change from baseline in incidence and titers of anti-drug antibodies against PF-07264660	Number of participants with the presence of anti-PF-07264660 antibodies	Baseline up to approximately 1.5 years
Secondary	Number of participants with change from baseline in incidence and titers of neutralizing antibodies against PF-07264660	Number of participants with the presence of anti-PF-07264660 antibodies	Baseline up to approximately 1.5 years

External Links

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