A Study to Learn How a Single Dose of the Study Medicine Called PF-08057418 is Tolerated in the Body of Healthy Adults.

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF SINGLE ASCENDING ORAL DOSES OF PF-08057418 IN HEALTHY ADULT PARTICIPANTS

The purpose of this clinical trial is to learn about the safety and pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from body after participant take it) of the study medicine (called PF-08057418) in healthy people.

This study is seeking participants who are healthy adults.

Everyone who participates in this study will receive the study medicine. The study medicine may be given as a solution or as a tablet. Participants will be dosed once a week for 5 weeks.

The investigator will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe.

Participants will be involved in this study for up to 13 weeks from screening to follow-up visit. Participants stay in the study clinic for the 5 week dosing duration of the study, with two follow-up visits subsequently, either in person or by telephone call.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-08057418; Other: Placebo (A placebo does not have any medicine in it but looks just like the medicine being studied.)

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults 18 to 60 years of age (or the minimum age of consent per local regulations) at screening.
• Healthy participants, as determined by medical history, physical examination, clinical laboratory tests, and cardiac monitoring.
• Body mass index (BMI) between 16 and 32 kg/m² and body weight >50 kg (110 lb).
• Willing and able to comply with all study procedures, including scheduled visits, treatment plans, laboratory testing, and lifestyle restrictions.

Exclusion Criteria:

• History or evidence of clinically significant medical conditions, including but not limited to hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic diseases (excluding untreated, asymptomatic seasonal allergies at the time of dosing).
• Any condition that may affect drug absorption (e.g., gastrectomy, cholecystectomy).
• History of HIV infection, hepatitis B, or hepatitis C, or positive screening tests for HIV, hepatitis B core antibody (HBcAb), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is permitted.
• History of phototoxicity or photosensitivity.
• Prior use of any investigational drug or vaccine within 30 days or 5 half-lives (whichever is longer) before the first study dose, or participation in another investigational study during this study.

• Elevated blood pressure at screening:

  • 140/90 mm Hg for participants <60 years, or
  • 150/90 mm Hg for participants ≥60 years, after at least 5 minutes of supine rest (average of 3 measurements).
• Renal impairment, defined as estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m².
• Clinically significant ECG abnormalities, including but not limited to QT corrected for heart rate by Fridericia's cube root formula (QTcF) >450 ms, complete left bundle branch block, evidence of myocardial infarction or ischemia, second- or third-degree AV block, or clinically significant arrhythmias.
• Clinically significant laboratory abnormalities at screening, including ALT, AST, or total bilirubin ≥1.05 × ULN (participants with Gilbert's syndrome may be eligible if direct bilirubin is ≤ULN).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-08057418; Participants will receive single oral solution or tablet dose(s) of PF-08057418	Drug: PF-08057418; solution or tablet (fasted/fed)
Placebo Comparator: Placebo; Participants will receive single oral solution or tablet dose(s) of placebo.	Other: Placebo (A placebo does not have any medicine in it but looks just like the medicine being studied.); solution or tablet (fasted/fed)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Assessment of TEAEs, SAEs, clinical laboratory values, vital signs, continuous cardiac monitoring and 12-lead ECGs	Up to 10 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (PK): Area under the concentration-time curve (AUC) of PF-08057418	Up to 10 weeks
PK: Maximum Observed Plasma Concentration (Cmax) of PF-08057418	Up to 10 weeks
PK: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-08057418	Up to 10 weeks

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): May 8, 2026
• Primary Completion (Estimated): July 23, 2026
• Study Completion (Estimated): July 23, 2026

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Healthy Participants; SAD; Single Ascending Dose; FIH; small molecule; PF-08057418
• Other Study ID Numbers: C6471002

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