PF-08049820 for Atopic Dermatitis

No longer recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Prescription drugs, Herbal supplements

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 6-11 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a new medicine, PF-08049820, designed for atopic dermatitis (a skin condition causing itchy, inflamed skin), behaves in the body. Researchers aim to determine how the medicine is absorbed and whether its formulation or consumption with a high-fat meal affects its efficacy. Participants will try five different versions of the medicine, including tablets that release the medicine quickly and slowly. This study suits men and women who are generally healthy, do not have serious medical problems, and can adhere to study rules, including staying at the clinic overnight. 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?

Yes, you will need to stop taking certain prescription or nonprescription drugs and dietary or herbal supplements at least 14 days before the study starts. This is to ensure that these substances do not affect how the study medicine works in your body.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that PF-08049820 has been tested in healthy adults to assess its safety. Earlier studies examined how this medicine works in the body and determined safe dosage levels. Participants in these studies used the medicine without major safety problems, and it appears to be generally well-tolerated, with most experiencing no serious side effects.

The current study is in an early phase, focusing on how the body processes the medicine and identifying any potential side effects. Although safety information is limited due to the early phase, no serious issues have been widely reported in the available data. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-08049820 for atopic dermatitis because it offers several novel features compared to standard treatments like topical corticosteroids and calcineurin inhibitors. Unlike these conventional options, PF-08049820 utilizes a modified release (MR) tablet format, which may improve how the medication is absorbed and utilized in the body. With both short and long MR formulations being tested, there's potential for customizing treatment to better manage symptoms under different conditions, such as whether the patient has eaten. Additionally, the immediate release (IR) version offers rapid delivery, potentially providing faster relief. This range of delivery options could lead to more personalized and effective treatment strategies for atopic dermatitis.

What evidence suggests that this trial's treatments could be effective for atopic dermatitis?

Research has shown that PF-08049820 is under study as a treatment for atopic dermatitis, also known as eczema. In this trial, participants will receive different formulations of PF-08049820, including Immediate Release (IR) and Modified Release (MR1 and MR2) tablets, under various conditions. Studies with patients who have moderate to severe eczema have shown that this treatment can reduce symptoms. The medicine targets specific parts of the immune system believed to cause skin inflammation and irritation. Early results from these studies suggest that PF-08049820 can help manage the condition by calming the skin's immune response. While more information is needed, initial findings are encouraging for people with this skin condition. ^{1 2 3 4 5}

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 who are at least 18 years old, weigh over 99 pounds, and have a body weight that's neither too low nor too high. Participants must be unable to have children and should not have serious medical conditions, recent drug use or certain vaccines. They need to commit to the study rules.

Inclusion Criteria

Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

I am 18 or older and cannot have children.

My BMI is between 16 and 32, and I weigh more than 99 lbs.

Exclusion Criteria

Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).

History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening.

I have a condition that might affect how drugs are absorbed in my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 5 different versions of the medicine, with 3 days between each dose, to study pharmacokinetics under fasted and fed conditions

6-11 weeks

Participants will stay overnight in the clinic for about 17 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PF-08049820 IR
• PF-08049820 MR1
• PF-08049820 MR2

Trial Overview

The study tests how different forms of PF-08049820 (immediate-release, short-release, long-release tablets) are absorbed into the bloodstream when taken orally with or without a high-fat meal. Participants will try each version separately with blood samples collected for up to 72 hours after dosing.

How Is the Trial Designed?

Group I: Treatment E Experimental Treatment 1 Intervention

Participants will receive a single dose of PF-08049820 IR tablets under fed conditions.

Group II: Treatment D Experimental Treatment 1 Intervention

Participants will receive a single dose of PF-08049820 MR2 tablets under fed conditions.

Group III: Treatment C Experimental Treatment 1 Intervention

Participants will receive a single dose of PF-08049820 Immediate Release (IR) tablets under fasted conditions.

Group IV: Treatment B Experimental Treatment 1 Intervention

Participants will receive a single dose of PF-08049820 long MR release rate (MR2) tablets under fasted conditions.

Group V: Treatment A Experimental Treatment 1 Intervention

Participants will receive a single dose of PF-08049820 short Modified release (MR) release rate (MR1) tablets under fasted conditions.

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

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07172321

NCT07172321 | A Study to Learn How Different Forms of ...

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. The scientists want to see:.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07216027

NCT07216027 | A Study to Learn About Study Medicine ...

The purpose of this study is to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as ...

3.

pfizerclinicaltrials.com

pfizerclinicaltrials.com/find-a-trial/nct06686797-healthy-trial

Clinical Trial Seeking Healthy Volunteers | Pfizer

The purpose of this study is to learn about the safety of the study medicine called PF-08049820 in healthy adults.

4.

withpower.com

withpower.com/trial/phase-1-dermatitis-atopic-8-2025-34854

PF-08049820 for Atopic Dermatitis · Info for Participants

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.

5.

synapse.patsnap.com

synapse.patsnap.com/drug/f652d6965d674e1e8ba29e73b026032c

PF-08049820 - Drug Targets, Indications, Patents

A Phase 1, Open-Label, Randomized, 5-Period, 6-Sequence, Crossover Study to Compare the Single-Dose Pharmacokinetics of One Immediate-Release and Two ...