PF-07264660 intravenous single ascending dose for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Clinical Trials of Texas, LLC, San Antonio, TX
Healthy Subjects (HS)
PF-07264660 subcutaneous multiple ascending dose - Drug
Eligibility
18+
All Sexes
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

11 Primary · 11 Secondary · Reporting Duration: Baseline up to approximately 1.5 years

Year 5
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
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
Number of participants with change from baseline in blood pressure
Number of participants with change from baseline in clinical laboratory values
Number of participants with change from baseline in corrected QT interval
Number of participants with change from baseline in heart rate
Number of participants with change from baseline in incidence and titers of anti-drug antibodies against PF-07264660
Number of participants with change from baseline in incidence and titers of neutralizing antibodies against PF-07264660
Number of participants with change from baseline in maximum plasma concentration (Cmax) of PF-07264660 after a single dose
Number of participants with change from baseline in maximum plasma concentration (Cmax) of PF-07264660 after multiple doses
Number of participants with change from baseline in pulse rate
Number of participants with change from baseline in temperature
Number of participants with change from baseline in terminal elimination half-life (t½) of PF-07264660 after a single dose
Number of participants with change from baseline in terminal elimination half-life (t½) of PF-07264660 after multiple doses
Number of participants with change from baseline in time to maximum plasma concentration (Tmax) of PF-07264660 after a single dose
Number of participants with change from baseline in time to maximum plasma concentration (Tmax) of PF-07264660 after multiple doses
Number of participants with treatment emergent treatment related adverse events (AE's)
Number of participants with treatment emergent treatment-related serious adverse events (SAE's)

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

PF-07264660 intravenous single ascending dose
1 of 4
PF-07264660 subcutaneous multiple ascending dose
1 of 4
Intravenous placebo
1 of 4
Subcutaneous Placebo
1 of 4
Experimental Treatment
Non-Treatment Group

75 Total Participants · 4 Treatment Groups

Primary Treatment: PF-07264660 intravenous single ascending dose · Has Placebo Group · Phase 1

PF-07264660 intravenous single ascending dose
Drug
Experimental Group · 1 Intervention: PF-07264660 intravenous single ascending dose · Intervention Types: Drug
PF-07264660 subcutaneous multiple ascending dose
Drug
Experimental Group · 1 Intervention: PF-07264660 subcutaneous multiple ascending dose · Intervention Types: Drug
Intravenous placebo
Other
PlaceboComparator Group · 1 Intervention: Intravenous placebo · Intervention Types: Other
Subcutaneous Placebo
Other
PlaceboComparator Group · 1 Intervention: subcutaneous placebo · Intervention Types: Other

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to approximately 1.5 years
Closest Location: Clinical Trials of Texas, LLC · San Antonio, TX
Photo of San Antonio  1Photo of San Antonio  2Photo of San Antonio  3
2020First Recorded Clinical Trial
2 TrialsResearching Healthy Subjects (HS)
5 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.