A Study to Learn How Different Amounts of the Study Medicine Called PF-07314470 Are Tolerated and Act in the Body in Healthy Adults

October 20, 2025 updated by: Pfizer

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 SUBCUTANEOUS DOSES OF PF-07314470 IN HEALTHY PARTICIPANTS

The purpose of this clinical trial is to learn if the study medicine (called PF-07314470) is safe and how it gets in and out of the body in healthy people.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Pfizer Clinical Research Unit - New Haven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria:

  • Healthy males aged 18 to 45 years and healthy females aged 18 to 55 years
  • Body Mass Index (BMI) of 16-32 kg/m2, and a total body weight greater than 50 kg (110 lb); for Japanese participants only, a total body weight greater than 45 kg
  • for Japanese participants only, enrolling as Japanese must have 4 biological grandparents who were born in Japan.

Key Exclusion Criteria:

  • Evidence or history of clinically significant medical or psychiatric conditions
  • Prior or current use of any prohibited medications
  • History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening
  • Pregnant or breastfeeding females, males with partners currently pregnant, or males or females pursuing artificial reproductive technologies
  • Use of tobacco/nicotine containing products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14
Participants will receive a single dose of PF-07314470 at 1 of 7 dose levels
Biological: PF-07314470
subcutaneous injection
Placebo Comparator: Placebo for PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14
Participants will receive a single dose of placebo for PF-07314470
Biological: Placebo for PF-07314470
subcutaneous injection
Experimental: PF-07314470; Cohorts 9 to 13
Participants will receive PF-07314470 weekly at 1 of 4 dose levels for 4 doses, or every 2 weeks at 1 dose level for 3 doses.
Biological: PF-07314470
subcutaneous injection
Placebo Comparator: Placebo for PF-07314470; Cohorts 9 to 13
Participants will receive placebo for PF-07314470 weekly for 4 doses, or every 2 weeks for 3 doses.
Biological: Placebo for PF-07314470
subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants with Treatment Emergent Adverse Events Following Single Doses
Time Frame: Day 1 up to approximately Day 35
Day 1 up to approximately Day 35
Number of Participants with Clinically Significant Change from Baseline in Laboratory Values Following Single Doses
Time Frame: Baseline up to approximately Day 35
Baseline up to approximately Day 35
Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following Single Doses
Time Frame: Baseline up to approximately Day 35
Baseline up to approximately Day 35
Number of Participants with Clinically Significant Change from Baseline in ECGs Following Single Doses
Time Frame: Baseline up to approximately Day 35
Baseline up to approximately Day 35
Number of Participants with Treatment Emergent Adverse Events Following Multiple Doses
Time Frame: Day 1 up to approximately Day 64
Day 1 up to approximately Day 64
Number of Participants with Clinically Significant Change from Baseline in Laboratory Values Following Multiple Doses
Time Frame: Baseline up to approximately Day 64
Baseline up to approximately Day 64
Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following Multiple Doses
Time Frame: Baseline up to approximately Day 64
Baseline up to approximately Day 64
Number of Participants with Clinically Significant Change from Baseline in ECGs Following Multiple Doses
Time Frame: Baseline up to approximately Day 64
Baseline up to approximately Day 64
Number of Participants with Serious Adverse Events Following Single Doses
Time Frame: Day 1 up to approximately Day 35
Day 1 up to approximately Day 35
Number of Participants with Serious Adverse Events Following Multiple Doses
Time Frame: Day 1 up to approximately Day 64
Day 1 up to approximately Day 64

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Measurable Concentration (AUClast) of PF-07314470 Following Single Doses
Time Frame: Day 1 up to approximately Day 35
Day 1 up to approximately Day 35
Maximum Observed Serum Concentration (Cmax) of PF-07314470 Following Single Doses
Time Frame: Day 1 up to approximately Day 35
Day 1 up to approximately Day 35
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07314470 Following Single Doses
Time Frame: Day 1 up to approximately Day 35
Day 1 up to approximately Day 35
Area Under the Serum Concentration-time Curve from Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07314470 Following Single Doses
Time Frame: Day 1 up to approximately Day 35
If data permit
Day 1 up to approximately Day 35
Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Single Doses
Time Frame: Day 1 up to approximately Day 35
If data permit
Day 1 up to approximately Day 35
Area Under the Serum Concentration-time Curve at Steady State Over the Dosing Interval (AUCtau) of PF-07314470 Following Multiple Doses
Time Frame: Day 1 up to approximately Day 64
Day 1 up to approximately Day 64
Maximum Observed Serum Concentration (Cmax) of PF-07314470 Following Multiple Doses
Time Frame: Day 1 up to approximately Day 64
Day 1 up to approximately Day 64
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07314470 Following Multiple Doses
Time Frame: Day 1 up to approximately Day 64
Day 1 up to approximately Day 64
Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Multiple Doses
Time Frame: Day 1 up to approximately Day 64
If data permit
Day 1 up to approximately Day 64
Incidence of the Development of Antidrug Antibodies Against PF-07314470 Following Single Doses
Time Frame: Day 1 up to approximately Day 35
Day 1 up to approximately Day 35
Incidence of the Development of Neutralizing Antibodies Against PF-07314470 Following Single Doses
Time Frame: Day up to approximately Day 35
If appropriate
Day up to approximately Day 35
Incidence of the Development of Antidrug Antibodies Against PF-07314470 Following Multiple Doses
Time Frame: Day 1 up to approximately Day 64
Day 1 up to approximately Day 64
Incidence of the Development of Neutralizing Antibodies Against PF-07314470 Following Multiple Doses
Time Frame: Day 1 up to approximately Day 64
If appropriate
Day 1 up to approximately Day 64

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 18, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C5271001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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