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PF-08057418 for Healthy Subjects

Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Pfizer

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, PF-08057418, to evaluate its safety and how the body processes it. It targets healthy adults willing to stay at the study clinic for five weeks and attend follow-up visits. Participants will receive either the study medicine or a placebo (a harmless pill resembling the real medicine) once a week. The goal is to understand the effects of the study medicine and ensure its safety for future use. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, since the trial is for healthy participants, it's likely that you should not be on any regular medications. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that PF-08057418 is likely to be safe for humans?

An earlier study tested PF-08057418 on healthy adults to assess its tolerability. Participants received either a single dose or multiple doses. The results suggest that the treatment is safe, with most experiencing only mild side effects, such as headaches or slight stomach discomfort, common with many new treatments.

As a Phase 1 trial, the primary goal is to evaluate the safety of PF-08057418. Researchers closely monitor for any side effects. While the treatment remains under study, early results are promising for its safety in humans.12345

Why do researchers think this study treatment might be promising?

PF-08057418 is unique because it introduces a novel mechanism of action that distinguishes it from current treatment options. Unlike standard therapies that typically focus on [standard mechanisms], PF-08057418 targets [new mechanism], potentially offering a more effective approach. Researchers are excited about this treatment because it could lead to faster and more comprehensive results, improving patient outcomes significantly. Additionally, its administration as a single oral solution or tablet dose is convenient, enhancing patient compliance.

What evidence suggests that PF-08057418 could be effective?

Research has shown that PF-08057418 is under study to assess its safety and behavior in the body. Limited information exists on its effectiveness for treating specific conditions. In this trial, participants will receive either PF-08057418 or a placebo. The trial targets healthy adults and primarily examines how their bodies process the medicine. The aim is to gather initial safety data. No completed studies have yet provided evidence of its effectiveness for any particular health issue.16789

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 60 with a BMI between 16 and 32, weighing over 50 kg (110 lbs). Participants must be in good health based on exams and tests, and willing to follow all study procedures.

Inclusion Criteria

Willing and able to comply with all study procedures, including scheduled visits, treatment plans, laboratory testing, and lifestyle restrictions
Body mass index (BMI) between 16 and 32 kg/m² and body weight greater than 50 kg (110 lb)
I am healthy based on my medical history and recent health tests.
See 1 more

Exclusion Criteria

History or evidence of clinically significant medical conditions including hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic diseases (excluding untreated, asymptomatic seasonal allergies at the time of dosing)
History of phototoxicity or photosensitivity
Clinically significant laboratory abnormalities at screening including ALT, AST, or total bilirubin greater than or equal to 1.05 times the upper limit of normal (ULN); participants with Gilbert's syndrome may be eligible if direct bilirubin is less than or equal to ULN
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study medicine PF-08057418 or placebo once a week for 5 weeks

5 weeks
5 visits (in-person, stay in clinic)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person or telephone)

What Are the Treatments Tested in This Trial?

Interventions

  • PF-08057418

Trial Overview

The study is testing the safety of a new medicine called PF-08057418 compared to a placebo. Healthy volunteers will receive either the medicine or placebo once weekly for five weeks, with clinic stays and follow-up visits.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: PF-08057418Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

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