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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-09

Study Completion Date

2024-05-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active

PF-07275315

Group Type EXPERIMENTAL

PF-07275315

Intervention Type DRUG

Active drug

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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PF-07275315

Active drug

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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No other name No other name

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes