NCT07575906 A Study to Learn How a Single Dose of the Study Medicine Called PF-08057418 is Tolerated in the Body of Healthy Adults.
| NCT ID | NCT07575906 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Pfizer |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2026-05-08 |
| Primary Completion | 2026-07-23 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 8 participants in total. It began in 2026-05-08 with a primary completion date of 2026-07-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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).
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT07575906 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07575906 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07575906 currently recruiting?
Yes, NCT07575906 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT07575906 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT07575906 clinical trial?
NCT07575906 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 8 participants.