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Pfizer tests new drug in healthy volunteers – first human doses underway

NCT ID NCT07575906

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This early-stage study tests a new medicine, PF-08057418, in healthy adults to see if it is safe and how the body processes it. Eight participants will receive single doses (as a solution or tablet) once a week for 5 weeks. The study is not intended to treat any disease, but to gather important safety information for future research.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

8 people

The number who actually took part.

Started

May 2026

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Pfizer Clinical Research Unit -New Haven

    New Haven, Connecticut, 06511, United States

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