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NCT06686797CompletedPhase 1

A Study to Learn How Different Amounts of the Study Medicine Called PF-08049820 Are Tolerated and Act in the Body in Healthy Adults

A PHASE 1, RANDOMIZED STUDY WITH DOUBLE-BLIND AND SPONSOR-OPEN, PLACEBO-CONTROLLED SINGLE- AND MULTIPLE-DOSE ESCALATION TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF-08049820 IN HEALTHY ADULT PARTICIPANTS

Source: ClinicalTrials.gov · Last updated 8 Sept 2026

Brief summary (registry, in English)

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 or cohort 3 only: 4. Have 4 biological Japanese grandparents who were born in Japan. The study has three parts: Part A, Part B and Part C. Part A consists of 3 groups (also known as "cohorts"). In Cohorts 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. Cohort 3 consists of one dosing period and will enroll participants who have 4 biological Japanese grandparents who were born in Japan. 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. Part B has 4 cohorts (Cohorts 4 to 7), each consisting of one dosing period. In all cohorts, participants will take multiple doses of the study medicine or placebo as tablets by mouth at the study clinic. Part C has two cohorts (Cohort 8 and 9), each consisting of one dosing period. In both cohorts, participants will take a single dose 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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
71 (actual)
First submitted
11 Nov 2024
Start date
27 Nov 2024
Primary completion date
23 Feb 2026
Lead sponsor
Pfizer
NCT number
NCT06686797

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 71
  • From 27 Nov 2024 to the primary completion date, 23 Feb 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.

Other illness

  • Evidence or history of clinically significant medical conditions.
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb).
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.

Who the study is looking for

  • Healthy males and females who can no longer have children.
  • Body mass index (BMI) of 16-32 kg/m2; and a total body weight \>50kg (110 lb.). Japanese participants only: a total body weight \>45 kg is acceptable.
    • Cohort 3 only:
  • Have 4 biological Japanese grandparents who were born in Japan

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pfizer Clinical Research Unit - New Haven
Coordinator of this site? Confirm its status
New HavenUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.