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

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: Terminated
• Conditions: Healthy
• Intervention / Treatment: Biological: PF-07314470; Biological: Placebo for PF-07314470

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Number of Participants with Treatment Emergent Adverse Events Following Single Doses	Day 1 up to approximately Day 35
Number of Participants with Clinically Significant Change from Baseline in Laboratory Values Following Single Doses	Baseline up to approximately Day 35
Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following Single Doses	Baseline up to approximately Day 35
Number of Participants with Clinically Significant Change from Baseline in ECGs Following Single Doses	Baseline up to approximately Day 35
Number of Participants with Treatment Emergent Adverse Events Following Multiple Doses	Day 1 up to approximately Day 64
Number of Participants with Clinically Significant Change from Baseline in Laboratory Values Following Multiple Doses	Baseline up to approximately Day 64
Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following Multiple Doses	Baseline up to approximately Day 64
Number of Participants with Clinically Significant Change from Baseline in ECGs Following Multiple Doses	Baseline up to approximately Day 64
Number of Participants with Serious Adverse Events Following Single Doses	Day 1 up to approximately Day 35
Number of Participants with Serious Adverse Events Following Multiple Doses	Day 1 up to approximately Day 64

Secondary Outcome Measures

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		Day 1 up to approximately Day 35
Maximum Observed Serum Concentration (Cmax) of PF-07314470 Following Single Doses		Day 1 up to approximately Day 35
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07314470 Following Single Doses		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	If data permit	Day 1 up to approximately Day 35
Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Single Doses	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		Day 1 up to approximately Day 64
Maximum Observed Serum Concentration (Cmax) of PF-07314470 Following Multiple Doses		Day 1 up to approximately Day 64
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07314470 Following Multiple Doses		Day 1 up to approximately Day 64
Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Multiple Doses	If data permit	Day 1 up to approximately Day 64
Incidence of the Development of Antidrug Antibodies Against PF-07314470 Following Single Doses		Day 1 up to approximately Day 35
Incidence of the Development of Neutralizing Antibodies Against PF-07314470 Following Single Doses	If appropriate	Day up to approximately Day 35
Incidence of the Development of Antidrug Antibodies Against PF-07314470 Following Multiple Doses		Day 1 up to approximately Day 64
Incidence of the Development of Neutralizing Antibodies Against PF-07314470 Following Multiple Doses	If appropriate	Day 1 up to approximately Day 64

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Actual): August 18, 2025
• Study Completion (Actual): August 18, 2025

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID 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