A PHASE 1, FIRST IN HUMAN, RANDOMIZED, DOUBLE-BLIND, SPONSOROPEN, PLACEBO-CONTROLLED, SINGLE- AND MULTIPLE DOSE ESCALATION, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-07832837 IN HEALTHY PARTICIPANTS AND PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single and repeat doses of PF-07832837 in healthy participants and in participants with moderate to severe atopic dermatitis. An additional goal is to assess the pharmacodynamics of PF-07832837 in participants with moderate to severe AD, including potential effects on clinical signs and symptoms
• Part 1 only: Adult participants between 18 to 55 years of age, inclusive, at the time of signing the ICD
• Part 2 only: Adult participants, who at the time of screening, are between the ages of 18 and 70 years, inclusive. Participants above 65 years need to be discussed with the sponsor.
• Part 1 only: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital sign assessments, temperature, 12-lead ECGs, laboratory tests
• BMI of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 lbs)
• Part 2 only: Must meet the following AD criteria:
‣ Have a clinical diagnosis of chronic AD (also known as atopic eczema) for approximately 1 year prior to Day 1 and have the diagnosis of AD confirmed by photographs (at screening) and diagnostic criteria for AD.
⁃ Either have had an inadequate response to treatment with topical medications (for at least 4 consecutive weeks within 1 year of the first dose of the study intervention). OR Have a documented reason why topical treatments are considered medically inappropriate within the last year.
⁃ Have moderate to severe AD (defined as having an affected BSA (captured as part of EASI) ≥10%, IGA ≥3, and EASI ≥12 at both the screening and baseline visits).
⁃ Have an otherwise healthy medical evaluation (other than signs and symptoms of AD) including medical history, physical examination, vital sign assessments, temperature, 12-lead ECGs, laboratory tests.
∙ Mild or moderate asthma that is well-controlled (not requiring high dose inhaled corticosteroids, systemic \[oral or parenteral\] corticosteroids, or biologic asthma treatments).