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OpenTrials
Completed

NCT Number: NCT07575906

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

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit -New Haven

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PF-08057418

Drug

solution or tablet (fasted/fed)

Placebo (A placebo does not have any medicine in it but looks just like the medicine being studied.)

Other

solution or tablet (fasted/fed)

Primary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 10 weeks

    Assessment of TEAEs, SAEs, clinical laboratory values, vital signs, continuous cardiac monitoring and 12-lead ECGs

Secondary outcomes

  1. Pharmacokinetics (PK): Area under the concentration-time curve (AUC) of PF-08057418

    Time frame: Up to 10 weeks

  2. PK: Maximum Observed Plasma Concentration (Cmax) of PF-08057418

    Time frame: Up to 10 weeks

  3. PK: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-08057418

    Time frame: Up to 10 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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