A Study to Learn How the Study Medicine Called PF-07275315 Works in Healthy People

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: PF-07275315

• Registration Number: NCT05411588
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) in healthy participants.

This study is seeking participants who:

* Are healthy as determined by medical evaluation.

* Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

* Have a body mass index (BMI) of 17.5 to 32 kilogram per meter square - a total body weight of more than 50 kilograms (110 pounds)

Participants will be divided randomly into 8 different groups. All participants will receive either one PF-07275315 or a harmless treatment that has no medical effect (placebo) intravenous (IV) infusion (given directly into a vein). Participants will take part in this study for up to 541 days. During this time, eligible participants will receive single increasing amounts of PF-07275315 or placebo. Increase will only occur if the sponsor agrees that the next dose is likely to have acceptable safety and tolerability. The follow-up visit will take place 271 days after first treatment.

Detailed Description

This is an first-in-human within-cohort randomized, participant- and investigator-blind, sponsor-open, placebo-controlled study of the safety, tolerability, PK, and PD following single and multiple escalating doses of PF-07275315 that will be conducted in healthy adults.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-06
• Study Start: 2022-06-09
• Study First Posted: 2022-06-09
• Status Verified: 2024-05
• Primary Completion: 2024-05-13
• Study Completion: 2024-05-13
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Active	PF-07275315	PF-07275315

Primary Outcome Measures

Name	Time	Method
Number of participants with clinically meaningful change from baseline in vital signs	Baseline through study completion, approximately 561 days	Number of participants with change from baseline in vital signs
Number of participants with Serious AEs (SAEs)	Baseline through study completion, approximately 561 days	Incidence and severity of SAEs
Number of participants with clinically meaningful change from baseline in ECG parameters	Baseline through study completion, approximately 561 days	number of participants with change from baseline in ECG parameters
Number of participants with Adverse Events (AEs)	Baseline through study completion, approximately 561 days	Incidence and severity of AEs
Number of participants with clinically meaningful change from baseline in laboratory Tests Results	Baseline through study completion, approximately 561 days	Number of Participants With Change From Baseline in Laboratory Tests Results

Secondary Outcome Measures

Name	Time	Method
Incidence of the development of neutralizing antibodies (NAb) against PF-07275315	1-561 days	To evaluate the immunogenicity profile of PF-07275315 in healthy adults.
Time to Maximum Plasma Concentration (Tmax) of PF-07275315	1 - 561 Days	Tmax will be observed directly from data.
AUC of PF-07275315 serum concentration time-profile over the dosing interval of 2 weeks or 336 hours	1-561 days	AUC336
Maximum Plasma Concentration (Cmax)	1- 561 Days	Cmax will be observed directly from data.
Area under the curve (AUC) of PF-07275315 serum concentration time-profile from time zero extrapolated to infinite time	1-561 days	AUCinf
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07275315	1 - 561 Days	Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast)
Incidence of the development of Antidrug antibodies (ADA) against PF-07275315	1 - 561 Days	To evaluate the immunogenicity profile of PF-07275315 in healthy adults.
Half-life of PF-07275315	1-561 days	terminal elimination half-life will be measured

Trial Locations

Locations (4)

Orange County Research Center; 🇺🇸 Tustin, California, United States

Qps-Mra, Llc; 🇺🇸 South Miami, Florida, United States

New Haven Clinical Research Unit; 🇺🇸 New Haven, Connecticut, United States

Pfizer Clinical Research Unit - Brussels; 🇧🇪 Brussels, Bruxelles-capitale, Région DE, Belgium