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

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-07275315 IN HEALTHY PARTICIPANTS

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: PF-07275315

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles-capitale, Région DE
    • Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
      • Pfizer Clinical Research Unit - Brussels
• United States
  • California
    • Lake Forest, California, United States, 92630
      • Orange County Research Center
    • Tustin, California, United States, 92780
      • Orange County Research Center
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • New Haven Clinical Research Unit
  • Florida
    • South Miami, Florida, United States, 33143
      • Qps-Mra, Llc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

This study is seeking participants who:

• Are overtly 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 kg/m2; and a total body weight >50 kg (110 lb).

This study is not seeking participants who have:

• Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by both of the following
• History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C;
• Any of the following acute or chronic infections or infection history
• 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.
• Have undergone significant trauma or major surgery within 1 month of the first dose of study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo; Other Names: No other name
Experimental: Active; PF-07275315	Drug: PF-07275315; Active drug; Other Names: No other name

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Estimated): April 22, 2024
• Study Completion (Estimated): April 22, 2024

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: PF-07275315
• Other Study ID Numbers: C4531001; 2022-000854-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No