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

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Biological: Placebo for PF-07314470; Biological: PF-07314470

• Registration Number: NCT06821750
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Study Start: 2025-02-11
• Study First Posted: 2025-02-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-24
• Primary Completion: 2026-06-09
• Study Completion: 2026-06-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 103

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo for PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14	Placebo for PF-07314470	Participants will receive a single dose of placebo for PF-07314470
Placebo for PF-07314470; Cohorts 9 to 13	Placebo for PF-07314470	Participants will receive placebo for PF-07314470 weekly for 4 doses, or every 2 weeks for 3 doses.
PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14	PF-07314470	Participants will receive a single dose of PF-07314470 at 1 of 7 dose levels
PF-07314470; Cohorts 9 to 13	PF-07314470	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.

Primary Outcome Measures

Name	Time	Method
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 Single Doses	Day 1 up to approximately Day 35
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 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 Treatment Emergent Adverse Events Following Multiple Doses	Day 1 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

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

Trial Locations

Locations (1)

Pfizer Clinical Research Unit - New Haven; 🇺🇸 New Haven, Connecticut, United States