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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05411588
Recruitment Status : Recruiting
First Posted : June 9, 2022
Last Update Posted : March 2, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: PF-07275315 Drug: Placebo Phase 1

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 9, 2022
Estimated Primary Completion Date : January 8, 2025
Estimated Study Completion Date : January 8, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Active
PF-07275315
 Drug: PF-07275315
Active drug
Other Name: No other name
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo
Other Name: No other name


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05411588


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, California
Orange County Research Center Recruiting
Tustin, California, United States, 92780
United States, Connecticut
New Haven Clinical Research Unit Recruiting
New Haven, Connecticut, United States, 06511
United States, Florida
Qps-Mra, Llc Recruiting
South Miami, Florida, United States, 33143
Belgium
Brussels Clinical Research Unit Recruiting
Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05411588    
Other Study ID Numbers: C4531001
2022-000854-27 ( EudraCT Number )
First Posted: June 9, 2022    Key Record Dates
Last Update Posted: March 2, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
PF-07275315