A Preliminary Study to Evaluate PF-07264660 in Healthy Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT05496738

Run by

Pfizer

People needed

59

Starts

2022-08-16

Expected to finish

2024-05-06

Last updated by the study team

2024-06-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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, United States

Full record on ClinicalTrials.gov

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