Clinical trial NCT05496738: A Preliminary Study to Evaluate PF-07264660 in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteers
Inteurleukin-33
Inteurleukin-4
Inteurleukin-13
IL-33
IL-4
IL-13
monoclonal antibody
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-08-11
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with treatment emergent treatment related adverse events (AE's)
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with treatment emergent treatment-related serious adverse events (SAE's)
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in blood pressure
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in pulse rate
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in temperature
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in clinical laboratory values
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in heart rate
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in QT interval
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in corrected QT interval
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in PR interval
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in QRS interval
timeFrame: Baseline up to approximately 1.5 years
Secondary outcomes:
measure: 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
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in maximum plasma concentration (Cmax) of PF-07264660 after a single dose
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in maximum plasma concentration (Cmax) of PF-07264660 after multiple doses
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in time to maximum plasma concentration (Tmax) of PF-07264660 after a single dose
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in time to maximum plasma concentration (Tmax) of PF-07264660 after multiple doses
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in terminal elimination half-life (t½) of PF-07264660 after a single dose
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in terminal elimination half-life (t½) of PF-07264660 after multiple doses
timeFrame: Baseline up to approximately 1.5 years
measure: 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
timeFrame: Baseline up to approximately 1.5 years
measure: 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
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in incidence and titers of anti-drug antibodies against PF-07264660
timeFrame: Baseline up to approximately 1.5 years
measure: Number of participants with change from baseline in incidence and titers of neutralizing antibodies against PF-07264660
timeFrame: Baseline up to approximately 1.5 years
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Los Alamitos
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Saint Paul
country: United States
facility: Prism Research LLC dba Nucleus Network
state: Minnesota
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
city: West Bend
country: United States
facility: Spaulding Clinical Research
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: