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Completed

NCT Number: NCT05411588

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

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - Brussels, Brussels, Bruxelles-capitale, Région de, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-07275315

Drug

Active drug

Other names: No other name

Placebo

Drug

Placebo

Other names: No other name

Primary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: Baseline through study completion, approximately 561 days

    Incidence and severity of AEs

  2. Number of participants with clinically meaningful change from baseline in laboratory Tests Results

    Time frame: Baseline through study completion, approximately 561 days

    Number of Participants With Change From Baseline in Laboratory Tests Results

  3. Number of participants with clinically meaningful change from baseline in vital signs

    Time frame: Baseline through study completion, approximately 561 days

    Number of participants with change from baseline in vital signs

  4. Number of participants with Serious AEs (SAEs)

    Time frame: Baseline through study completion, approximately 561 days

    Incidence and severity of SAEs

  5. Number of participants with clinically meaningful change from baseline in ECG parameters

    Time frame: Baseline through study completion, approximately 561 days

    number of participants with change from baseline in ECG parameters

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: 1- 561 Days

    Cmax will be observed directly from data.

  2. Time to Maximum Plasma Concentration (Tmax) of PF-07275315

    Time frame: 1 - 561 Days

    Tmax will be observed directly from data.

  3. Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07275315

    Time frame: 1 - 561 Days

    Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast)

  4. Incidence of the development of Antidrug antibodies (ADA) against PF-07275315

    Time frame: 1 - 561 Days

    To evaluate the immunogenicity profile of PF-07275315 in healthy adults.

  5. Half-life of PF-07275315

    Time frame: 1-561 days

    terminal elimination half-life will be measured

  6. Area under the curve (AUC) of PF-07275315 serum concentration time-profile from time zero extrapolated to infinite time

    Time frame: 1-561 days

    AUCinf

  7. AUC of PF-07275315 serum concentration time-profile over the dosing interval of 2 weeks or 336 hours

    Time frame: 1-561 days

    AUC336

  8. Incidence of the development of neutralizing antibodies (NAb) against PF-07275315

    Time frame: 1-561 days

    To evaluate the immunogenicity profile of PF-07275315 in healthy adults.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2022
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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