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

NCT05411588

CompletedPhase 1

Sponsor: Pfizer

Conditions: Healthy Volunteers

Interventions: PF-07275315, Placebo

Countries: United States, Belgium

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (5)
  • Lake Forest, California, United States
  • Tustin, California, United States
  • New Haven, Connecticut, United States
  • South Miami, Florida, United States
  • Brussels, Bruxelles-capitale, Région de, Belgium