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HealthyPhase 1NCT05496738

A Preliminary Study to Evaluate PF-07264660 in Healthy Participants

A Phase 1 study testing PF-07264660 intravenous single ascending dose and PF-07264660 subcutaneous multiple ascending dose in people with Healthy, run by Pfizer at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PF-07264660 intravenous single ascending dose and PF-07264660 subcutaneous multiple ascending dose
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
59 participants
Where
6 sitesUnited States
Study dates
16 Aug 2022to 6 May 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
Show all 18Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Collaborative Neuroscience Research, LLC

    Garden Grove, California, 92845

  • Collaborative Neuroscience Research, LLC

    Long Beach, California, 90806

  • Collaborative Neuroscience Research, LLC

    Los Alamitos, California, 90720

  • Prism Research LLC dba Nucleus Network

    Saint Paul, Minnesota, 55114

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229

  • Spaulding Clinical Research

    West Bend, Wisconsin, 53095

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Healthy
Being tested
PF-07264660 intravenous single ascending dose, PF-07264660 subcutaneous multiple ascending dose, Intravenous placebo, subcutaneous placebo
Keywords
Healthy volunteers, Inteurleukin-33, Inteurleukin-4, Inteurleukin-13, IL-33, IL-4, IL-13, monoclonal antibody

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-07264660 intravenous single ascending doseDrug

    PF-07264660 will be administered intravenously in single ascending doses

  • PF-07264660 subcutaneous multiple ascending doseDrug

    PF-07264660 will be administered subcutaneously in multiple ascending doses

  • Intravenous placeboOther

    Placebo will be administered intravenously in single ascending doses

  • subcutaneous placeboOther

    Placebo will be administered subcutaneously in multiple ascending doses

Study groups in NCT05496738
Study groupRoleWhat they receive
PF-07264660 intravenous single ascending doseExperimentalPF-07264660 will be administered intravenously
Receives: Drug: PF-07264660 intravenous single ascending dose
PF-07264660 subcutaneous multiple ascending doseExperimentalPF-07264660 will be administered subcutaneously
Receives: Drug: PF-07264660 subcutaneous multiple ascending dose
Intravenous placeboPlacebo comparatorPlacebo will be administered intravenously
Receives: Other: Intravenous placebo
Subcutaneous PlaceboPlacebo comparatorPlacebo will be administered subcutaneously
Receives: Other: subcutaneous placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline up to approximately 1.5 years

  2. 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

    Measured: Baseline up to approximately 1.5 years

  3. 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

    Measured: Baseline up to approximately 1.5 years

  4. 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

    Measured: Baseline up to approximately 1.5 years

  5. 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

    Measured: Baseline up to approximately 1.5 years

  6. Number of participants with change from baseline in clinical laboratory values

    Identify laboratory abnormalities from baseline will be summarized

    Measured: Baseline up to approximately 1.5 years

  7. 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

    Measured: Baseline up to approximately 1.5 years

  8. 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

    Measured: Baseline up to approximately 1.5 years

  9. 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

    Measured: Baseline up to approximately 1.5 years

  10. 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

    Measured: Baseline up to approximately 1.5 years

  11. 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

    Measured: Baseline up to approximately 1.5 years

Secondary outcomes (11)

  1. 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

    Measured: Baseline up to approximately 1.5 years

  2. 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

    Measured: Baseline up to approximately 1.5 years

  3. 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

    Measured: Baseline up to approximately 1.5 years

  4. 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

    Measured: Baseline up to approximately 1.5 years

  5. 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

    Measured: Baseline up to approximately 1.5 years

  6. 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

    Measured: Baseline up to approximately 1.5 years

  7. 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

    Measured: Baseline up to approximately 1.5 years

  8. 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

    Measured: Baseline up to approximately 1.5 years

  9. 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

    AUC of PF 07264660 will be calculated at selected timepoints

    Measured: Baseline up to approximately 1.5 years

  10. 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

    Measured: Baseline up to approximately 1.5 years

  11. 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

    Measured: Baseline up to approximately 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2022
  2. Study start16 Aug 2022
  3. Primary completion6 May 2024
  4. Study completion6 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05496738
Sponsor's protocol ID
C4521001
Status last verified
Jun 2024
First submitted
9 Aug 2022
Last updated
6 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07264660 intravenous single ascending dose and PF-07264660 subcutaneous multiple ascending dose in people with Healthy, run by Pfizer at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment emergent treatment related adverse events (AE's) (time frame: Baseline up to approximately 1.5 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05496738.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.

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