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

Healthy Volunteers Clinical Trial

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-07275315 IN HEALTHY PARTICIPANTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05411588
• Other study ID #: C4531001
• Secondary ID: 2022-000854-27
• Status: Completed
• Phase: Phase 1
• Start date: June 9, 2022
• Est. completion date: May 13, 2024

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 13, 2024
• Est. primary completion date: May 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• PF-07275315
Active drug
• Placebo
Placebo

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit - Brussels	Brussels	Bruxelles-capitale, Région DE
United States	Orange County Research Center	Lake Forest	California
United States	New Haven Clinical Research Unit	New Haven	Connecticut
United States	Qps-Mra, Llc	South Miami	Florida
United States	Orange County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events (AEs)	Incidence and severity of AEs	Baseline through study completion, approximately 561 days
Primary	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
Primary	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
Primary	Number of participants with Serious AEs (SAEs)	Incidence and severity of SAEs	Baseline through study completion, approximately 561 days
Primary	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	Maximum Plasma Concentration (Cmax)	Cmax will be observed directly from data.	1- 561 Days
Secondary	Time to Maximum Plasma Concentration (Tmax) of PF-07275315	Tmax will be observed directly from data.	1 - 561 Days
Secondary	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
Secondary	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
Secondary	Half-life of PF-07275315	terminal elimination half-life will be measured	1-561 days
Secondary	Area under the curve (AUC) of PF-07275315 serum concentration time-profile from time zero extrapolated to infinite time	AUCinf	1-561 days
Secondary	AUC of PF-07275315 serum concentration time-profile over the dosing interval of 2 weeks or 336 hours	AUC336	1-561 days
Secondary	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

External Links

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