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

NCT07575906 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: C6471002
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 your body after you 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. We 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.

Conditions

Healthy

Keywords

PF-08057418; SAD; Single Ascending Dose; FIH; Healthy Participants; small molecule; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

PF-08057418

EXPERIMENTAL

Participants will receive single oral solution or tablet dose(s) of PF-08057418

Drug: PF-08057418

Placebo

PLACEBO COMPARATOR

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.)

Interventions

PF-08057418 DRUG

solution or tablet (fasted/fed)

PF-08057418

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

solution or tablet (fasted/fed)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• /90 mm Hg for participants \<60 years, or
• /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).

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: May 8, 2026
• Primary Completion (Estimated): July 23, 2026
• Study Completion (Estimated): July 23, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share