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

NCT06821750 | Terminated Phase 1 FDA Drug

• 1 other identifier: C5271001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (13)

• 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

  Day 1 up to approximately Day 35

• Terminal Serum Elimination Half-life (t 1/2) of PF-07314470 Following Single Doses

  Day 1 up to approximately Day 35

Study Arms (4)

PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14

EXPERIMENTAL

Participants will receive a single dose of PF-07314470 at 1 of 7 dose levels

Biological: PF-07314470

Placebo for PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14

PLACEBO COMPARATOR

Participants will receive a single dose of placebo for PF-07314470

Biological: Placebo for PF-07314470

PF-07314470; Cohorts 9 to 13

EXPERIMENTAL

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

Placebo for PF-07314470; Cohorts 9 to 13

PLACEBO COMPARATOR

Participants will receive placebo for PF-07314470 weekly for 4 doses, or every 2 weeks for 3 doses.

Biological: Placebo for PF-07314470

Interventions

PF-07314470 BIOLOGICAL

subcutaneous injection

PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14; PF-07314470; Cohorts 9 to 13

Placebo for PF-07314470 BIOLOGICAL

subcutaneous injection

Placebo for PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14; Placebo for PF-07314470; Cohorts 9 to 13

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: February 11, 2025
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)