53 Participants Needed

PF-08049820 for Eczema

PC
Overseen ByPfizer CT.gov Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Pfizer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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 processes the study medicine and * if food affects the amount of study medicine in the blood. The study medicine is developed for the treatment of moderate to severe atopic dermatitis, also known as eczema. People with this condition may have severe itching and rashes on the skin. The study is seeking participants who: 1. Are males or females who can no longer have children. 2. Are 18 to 65 years old. 3. Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds). For group 3 only: 4. Have 4 biological Japanese grandparents who were born in Japan. The study has two parts: Part A and Part B. Part A consists of 3 groups. In groups 1 and 2, there may be up to four dosing periods. During each dosing period, participants will take a single dose of the study medicine or placebo as liquid by mouth with or without food at the study clinic. A placebo does not have any medicine in it but looks just like the medicine being studied. The participants will stay at the study clinic for about 8 days and then can go home. During this time, the study team will observe the participants and take some urine and blood samples to test the level of the study medicine. The participants will return to the study clinic up to three more times to complete up to four dosing periods separated by at least 2 weeks. The participants will take increasing amounts of study medicine during each dosing period. After completion of the final dosing period, the participants will receive a follow-up telephone call about a month later. Group 3 may or may not be needed and will be decided by the study team if needed to collect results from participants who have 4 biological Japanese grandparents who were born in Japan. If group 3 is needed, then there will only be one dosing period as described above. Part B has 4 groups (Groups 4 to 7), each consisting of one dosing period. In all groups, participants will take multiple doses of the study medicine or placebo as tablets by mouth at the study clinic. Participants will be checked as described above and will receive a follow-up telephone call about one month after the last dose of study medicine or placebo. Group 7 may or may not be needed, depending on the results from previous groups, and will be decided by the study team.

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.

Research Team

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

I am healthy and cannot have children.
My BMI is between 16 and 32, and I weigh more than 110 lbs (or more than 45 kg if I am Japanese).
All four of my grandparents were born in Japan and are biologically related to me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

8 days per dosing period, with at least 2 weeks between periods
Up to 4 visits (in-person) per dosing period

Follow-up

Participants receive a follow-up telephone call about a month after the final dosing period to monitor for safety and effectiveness.

4 weeks

Treatment Details

Interventions

  • PF-08049820
Trial OverviewPF-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.
Participant Groups
7Treatment groups
Experimental Treatment
Group I: Part B: Cohort 7 - OptionalExperimental Treatment2 Interventions
One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants.
Group II: Part B: Cohort 6Experimental Treatment2 Interventions
One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants.
Group III: Part B: Cohort 5Experimental Treatment2 Interventions
One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants.
Group IV: Part B: Cohort 4Experimental Treatment2 Interventions
One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants.
Group V: Part A: Cohort 3 - OptionalExperimental Treatment2 Interventions
One dosing period with a single dose of PF-08049820 or placebo in healthy adult Japanese participants.
Group VI: Part A: Cohort 2Experimental Treatment2 Interventions
Up to 4 dosing periods in healthy adult participants. Each period consists of a single dose of PF-08049820 or placebo.
Group VII: Part A: Cohort 1Experimental Treatment2 Interventions
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

Trials
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Recruited
50,980,000+
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Vaccine Innovations
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Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

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Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University