A Preliminary Study to Evaluate PF-07264660 in Healthy Participants

NCT05496738 | Completed Phase 1 FDA Drug

• 1 other identifier: C4521001
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Healthy

Keywords

Healthy volunteers; Inteurleukin-33; Inteurleukin-4; Inteurleukin-13; IL-33; IL-4; IL-13; monoclonal antibody

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (11)

• 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

• Number of participants with change from baseline in time to maximum plasma concentration (Tmax) of PF-07264660 after a single dose

  Baseline up to approximately 1.5 years

• Number of participants with change from baseline in time to maximum plasma concentration (Tmax) of PF-07264660 after multiple doses

  Baseline up to approximately 1.5 years

Study Arms (4)

PF-07264660 intravenous single ascending dose

EXPERIMENTAL

PF-07264660 will be administered intravenously

Drug: PF-07264660 intravenous single ascending dose

PF-07264660 subcutaneous multiple ascending dose

EXPERIMENTAL

PF-07264660 will be administered subcutaneously

Drug: PF-07264660 subcutaneous multiple ascending dose

Intravenous placebo

PLACEBO COMPARATOR

Placebo will be administered intravenously

Other: Intravenous placebo

Subcutaneous Placebo

PLACEBO COMPARATOR

Placebo will be administered subcutaneously

Other: subcutaneous placebo

Interventions

PF-07264660 intravenous single ascending dose DRUG

PF-07264660 will be administered intravenously in single ascending doses

PF-07264660 intravenous single ascending dose

PF-07264660 subcutaneous multiple ascending dose DRUG

PF-07264660 will be administered subcutaneously in multiple ascending doses

PF-07264660 subcutaneous multiple ascending dose

Intravenous placebo OTHER

Placebo will be administered intravenously in single ascending doses

Intravenous placebo

subcutaneous placebo OTHER

Placebo will be administered subcutaneously in multiple ascending doses

Subcutaneous Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (6)

Collaborative Neuroscience Research, LLC

Garden Grove, California, 92845, United States

Location

Collaborative Neuroscience Research, LLC

Long Beach, California, 90806, United States

Location

Collaborative Neuroscience Research, LLC

Los Alamitos, California, 90720, United States

Location

Prism Research LLC dba Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

Spaulding Clinical Research

West Bend, Wisconsin, 53095, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Investigators and other site staff will be blinded to participants' assigned study intervention. Participants will be assigned to receive study intervention according to the assigned treatment group from the randomization scheme. Investigators will remain blinded to each participant's assigned study intervention throughout the course of the study. In the event of a Quality Assurance audit, the auditor(s) will be allowed access to unblinded study intervention records at the site(s) to verify that randomization/dispensing has been done accurately. Sponsor staff not directly involved in the conduct of the study will be unblinded to participants' assigned study intervention.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: August 16, 2022
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)