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Unknown

PF-07264660 for Healthy Volunteers

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 1.5 years
Awards & highlights

Study Summary

This trial is testing the safety and effects of PF-07264660 compared to a placebo. It is the first study of this drug in humans. The drug will be given by shots under the skin or through a vein, depending on which group the participant is assigned to. Part A will receive the drug once and stay overnight 3-5 times, while Part B will receive the drug three times and stay overnight 3-5 times. Participants will be in the study for 541 (A) or 561 (B) days.

Who is the study for?
Healthy adults aged 18-65 with a BMI of 17.5 to 32 and weighing over 50 kg may join this study on PF-07264660, a new drug. Exclusions include tuberculosis, frequent infections, non-compliance with COVID-19 vaccination protocols, history of certain diseases like lymphoma or leukemia, substance abuse within the last six months, heavy smoking, recent blood donations or surgeries.Check my eligibility
What is being tested?
The trial is testing PF-07264660 given either as an injection under the skin or through a vein compared to placebo. Participants will be randomly assigned to receive the drug once or three times across several days with follow-up visits lasting up to about 541 or 561 days respectively.See study design
What are the potential side effects?
Since this is the first time PF-07264660 is being tested in humans, specific side effects are unknown but could include typical reactions related to injections such as pain at the injection site, feverish symptoms post-dosing and potential allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with change from baseline in PR interval
Number of participants with change from baseline in QRS interval
Number of participants with change from baseline in QT interval
+8 more
Secondary outcome measures
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
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
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
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: PF-07264660 subcutaneous multiple ascending doseExperimental Treatment1 Intervention
PF-07264660 will be administered subcutaneously
Group II: PF-07264660 intravenous single ascending doseExperimental Treatment1 Intervention
PF-07264660 will be administered intravenously
Group III: Intravenous placeboPlacebo Group1 Intervention
Placebo will be administered intravenously
Group IV: Subcutaneous PlaceboPlacebo Group1 Intervention
Placebo will be administered subcutaneously

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,910,381 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,091,495 Total Patients Enrolled

Media Library

PF-07264660 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05496738 — Phase 1
Healthy Subjects Research Study Groups: PF-07264660 intravenous single ascending dose, PF-07264660 subcutaneous multiple ascending dose, Intravenous placebo, Subcutaneous Placebo
Healthy Subjects Clinical Trial 2023: PF-07264660 Highlights & Side Effects. Trial Name: NCT05496738 — Phase 1
PF-07264660 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05496738 — Phase 1
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05496738 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous facilities in North America administering this trial?

"The trial is currently being run at 5 sites, with San Antonio, Saint Paul and Garden Grove included among the locations. To limit travel demands for prospective participants, it is beneficial to pick a clinic closest in proximity to your residence."

Answered by AI

Who is qualified to participate in this research endeavor?

"The prerequisites for this clinical trial necessitate that applicants are betwixt 18 and 65 years of age, possess healthy subjects (hs), with a maximum recruitment goal of 75 patients."

Answered by AI

Are there any open enrollment opportunities for this experiment?

"Clinicaltrials.gov's records affirm that recruitment for this study is still in progress. The trial was first posted on August 16th 2022 and the details were most recently revised on October 24th of the same year."

Answered by AI

What effects are researchers aiming to observe with this clinical trial?

"This study's primary outcome, which will be tracked between its baseline and final assessment point of 18 months, is the number of participants to experience adverse events (AEs) in response to treatment. Secondary outcomes include analyzing changes from baseline maximum plasma concentration (Cmax), peak concentrations at selected timepoints after multiple doses, and the time taken for PF-07264660 to reach its peak concentration following a single dose."

Answered by AI

How many participants are enrolled in this experiment?

"Affirmative. According to the details on clinicaltrials.gov, this medical research project began recruiting participants since August 16th 2022 and is still ongoing. At present, they are seeking 75 individuals from 5 separate sites."

Answered by AI

What dangers might be associated with a single intravenous dose of PF-07264660?

"In spite of limited data regarding safety and efficacy, PF-07264660 intravenous single ascending dose was provisionally assigned a score of 1 by the Power research team due to this being an initial Phase 1 trial."

Answered by AI

Are seniors aged 55 and above suitable candidates to join this clinical investigation?

"As per the guidelines of this trial, the minimum enrolment age is 18 while individuals aged 65 or older are ineligible to participate."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
Other
Texas
California
How old are they?
65+
What site did they apply to?
Spaulding Clinical Research
Other
Collaborative Neuroscience Research, LLC
Clinical Trials of Texas, LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Interested in a clinical trial to make a difference!
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Collaborative Neuroscience Research, LLC: < 24 hours
  2. Prism Research LLC dba Nucleus Network: < 48 hours
Typically responds via
Phone Call
Email
Recent research and studies
clinicaltrials.govStudy
A Preliminary Study to Evaluate PF-07264660 in Healthy Participants
2022. "A Preliminary Study to Evaluate PF-07264660 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05496738.
~0 spots leftby Apr 2024
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