Pfizer tests new drug in healthy volunteers – first human doses underway
NCT ID NCT07575906
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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8 people
The number who actually took part.
- Started
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May 2026
- Finished
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Jul 2026
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Pfizer Clinical Research Unit -New Haven
New Haven, Connecticut, 06511, United States
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