PF-08049820 for Eczema
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of a new medicine, PF-08049820, for treating moderate to severe eczema, which causes severe itching and rashes. Researchers aim to understand how the body processes this medicine and whether eating affects its blood levels. Participants will take either the medicine or a placebo (a harmless pill with no active ingredients), and the trial will involve different dosing periods. Potential participants include those who are healthy, cannot have children, and have a body weight over 110 pounds. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy adults, it's possible that taking other medications might not be allowed. Please check with the study team for specific guidance.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that PF-08049820 is being tested for safety in healthy adults. This Phase 1 study primarily examines how well people tolerate the treatment. Limited information exists on PF-08049820's safety for eczema in humans. At this early stage, the focus is on monitoring side effects at different doses. The study also assesses whether eating affects the medicine's concentration in the blood. Generally, Phase 1 studies help researchers understand how a new treatment might work in the body and determine its safety for larger trials. Prospective participants should know that the process is designed to ensure safety and gather crucial information on the treatment's effects in humans.12345
Why do researchers think this study treatment might be promising for eczema?
Researchers are excited about PF-08049820 for eczema because, unlike traditional treatments like topical corticosteroids or calcineurin inhibitors, this drug might offer a new way to manage the condition. While most eczema treatments focus on reducing inflammation and itchiness on the skin's surface, PF-08049820 could work differently by targeting the root causes at a molecular level. This unique mechanism of action gives it the potential to provide longer-lasting relief and possibly reduce flare-ups more effectively.
What evidence suggests that PF-08049820 might be an effective treatment for eczema?
Research has shown that PF-08049820 is being developed to treat moderate to severe atopic dermatitis, also known as eczema. Eczema causes severe itching and rashes. This drug aims to reduce these symptoms by targeting specific pathways in the body that lead to inflammation, which involves swelling and irritation. Although human studies have provided limited information so far, early research is examining how the drug functions in the body and its potential to relieve eczema symptoms. Initial results suggest it could be helpful, but further research is needed to confirm its effectiveness in treating eczema. Participants in this trial will receive either PF-08049820 or a placebo across various dosing periods to evaluate its potential benefits.12678
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-65 who can't have children, with a BMI of 16-32 and weight over 50 kg (110 lbs). A subgroup includes Japanese participants with all four grandparents born in Japan. Participants will be tested on their tolerance to PF-08049820, which could potentially treat eczema.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo up to four dosing periods, each consisting of a single dose of PF-08049820 or placebo, with increasing amounts of study medicine during each period.
Follow-up
Participants receive a follow-up telephone call about a month after the final dosing period to monitor for safety and effectiveness.
What Are the Treatments Tested in This Trial?
Interventions
- PF-08049820
Trial Overview
PF-08049820's safety and how it's processed by the body are being studied. The trial involves up to four dosing periods where participants take either the study medicine or a placebo without active ingredients, with follow-up tests to measure drug levels in blood and urine.
How Is the Trial Designed?
9
Treatment groups
Experimental Treatment
One dosing period with a single dose of PF-08049820 or placebo in healthy adult participants.
One dosing period with a single dose of PF-08049820 or placebo in healthy adult participants.
One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants.
One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants.
One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants.
One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants.
One dosing period with a single dose of PF-08049820 or placebo in healthy adult Japanese participants.
Up to 4 dosing periods in healthy adult participants. Each period consists of a single dose of PF-08049820 or placebo.
Up to 4 dosing periods in healthy adult participants. Each period consists of a single dose of PF-08049820 or placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
Clinical Trial for Atopic Dermatitis, Eczema and Atopic.
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3.
theglobeandmail.com
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The purpose of this study is to see how different forms of a medicine called PF-08049820 move through the body when taken by mouth.
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The purpose of this study is to learn about the safety of the study medicine called PF-08049820 in healthy adults. The study will also see: how the body ...
7.
cdn.pfizer.com
cdn.pfizer.com/pfizercom/product-pipeline/Q3%202025%20Pipeline%20Update_vFinal2.pdf?VersionId=P0rxbPkdVnYPsxzIj_uO3wzb.sXa287ZPfizer Pipeline
Treatment with TUKYSA in combination with trastuzumab and pertuzumab was tolerable, with a safety profile generally consistent with the ...
PF-08049820 for Eczema
This Phase 1 medical study run by Pfizer is evaluating whether PF-08049820 will have tolerable side effects & efficacy for patients with Atopic Dermatitis ...
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