NCT05411588

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Jun 2022

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 9, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2024

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

June 6, 2022

Last Update Submit

May 22, 2025

Conditions

Healthy Volunteers

Keywords

PF-07275315

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (8)

  • Maximum Plasma Concentration (Cmax)

    1- 561 Days

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

    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

    1 - 561 Days

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

    1 - 561 Days

  • Half-life of PF-07275315

    1-561 days

  • +3 more secondary outcomes

Study Arms (2)

Active

EXPERIMENTAL

PF-07275315

Drug: PF-07275315

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PF-07275315DRUG

Active drug

Also known as: No other name
Active
PlaceboDRUG

Placebo

Also known as: No other name
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Orange County Research Center

Lake Forest, California, 92630, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Qps-Mra, Llc

South Miami, Florida, 33143, United States

Location

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2022

First Posted

June 9, 2022

Study Start

June 9, 2022

Primary Completion

May 13, 2024

Study Completion

May 13, 2024

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

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.

Locations

BE(1)US(4)