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

NCT06686797 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: C6231001NCT06686797
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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:
• Are males or females who can no longer have children,
• Are 18 to 65 years old,
• 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).
• Have 4 biological Japanese grandparents who were born in Japan.

Conditions

Healthy

Keywords

Atopic Dermatitis

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)

  Baseline up to Day 35 of last dosing period for Parts A and C and up to Day 45 for Part B

• Number of Participants With Serious Adverse Events (SAEs)

  Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)

  Baseline up to Day 35 of last dosing period for Parts A and C and up to Day 45 for Part B

• Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities

  Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)

  Baseline up to Day 21 of last dosing period for Parts A and C and up to Day 31 for Part B

• Number of Participants With Clinically Significant Change From Baseline in Vital Signs

  Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)

  Baseline up to Day 21 of last dosing period for Parts A and C and up to Day 31 for Part B

• Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings

  Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)

  Baseline up to Day 21 of last dosing period for Parts A and C and up to Day 31 for Part B

Secondary Outcomes (9)

• Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)

  Baseline up to Day 8 of last dosing period for Parts A and C

• Area under the curve from time zero to end of dosing interval (AUCtau)

  Baseline up to Day 13 for Part B

• Maximum observed plasma concentration (Cmax)

  Baseline up to Day 8 of last dosing period for Parts A and C and up to Day 13 for Part B

• Time to reach maximum observed plasma concentration (Tmax)

  Baseline up to Day 8 of last dosing period for Parts A and C and up to Day 13 for Part B

• Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit

  Baseline up to Day 8 of last dosing period for Parts A and C and up to Day 13 for Part B

Study Arms (9)

Part A: Cohort 1

EXPERIMENTAL

Up to 4 dosing periods in healthy adult participants. Each period consists of a single dose of PF-08049820 or placebo.

Drug: PF-08049820; Drug: Placebo

Part A: Cohort 2

EXPERIMENTAL

Up to 4 dosing periods in healthy adult participants. Each period consists of a single dose of PF-08049820 or placebo.

Drug: PF-08049820; Drug: Placebo

Part A: Cohort 3

EXPERIMENTAL

One dosing period with a single dose of PF-08049820 or placebo in healthy adult Japanese participants.

Drug: PF-08049820; Drug: Placebo

Part B: Cohort 4

EXPERIMENTAL

One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants.

Drug: PF-08049820; Drug: Placebo

Part B: Cohort 5

EXPERIMENTAL

One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants.

Drug: PF-08049820; Drug: Placebo

Part B: Cohort 6

EXPERIMENTAL

One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants.

Drug: PF-08049820; Drug: Placebo

Part B: Cohort 7

EXPERIMENTAL

One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants.

Drug: PF-08049820; Drug: Placebo

Part C: Cohort 8

EXPERIMENTAL

One dosing period with a single dose of PF-08049820 or placebo in healthy adult participants.

Drug: PF-08049820; Drug: Placebo

Part C: Cohort 9

EXPERIMENTAL

One dosing period with a single dose of PF-08049820 or placebo in healthy adult participants.

Drug: PF-08049820; Drug: Placebo

Interventions

PF-08049820 DRUG

Oral solution/suspension for Part A (Cohorts 1 to 3). Tablets for Parts B and C (Cohorts 4 to 9).

Part A: Cohort 1; Part A: Cohort 2; Part A: Cohort 3; Part B: Cohort 4; Part B: Cohort 5; Part B: Cohort 6; Part B: Cohort 7; Part C: Cohort 8; Part C: Cohort 9

Placebo DRUG

Oral solution/suspension for Part A (Cohorts 1 to 3). Tablets for Parts B and C (Cohorts 4 to 9).

Part A: Cohort 1; Part A: Cohort 2; Part A: Cohort 3; Part B: Cohort 4; Part B: Cohort 5; Part B: Cohort 6; Part B: Cohort 7; Part C: Cohort 8; Part C: Cohort 9

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind, sponsor-open study.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: November 27, 2024
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)