FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients

Last updated: May 12, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

1

Condition

Dermatitis, Atopic

Allergy

Skin Infections/disorders

Treatment

Placebo

PF-07832837

Clinical Study ID

NCT06564389
C4991001
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Part 1 only: Adult participants between 18 to 55 years of age, inclusive, at thetime of signing the ICD

  • Part 2 only: Adult participants, who at the time of screening, are between the agesof 18 and 70 years, inclusive. Participants above 65 years need to be discussed withthe sponsor.

  • Part 1 only: Participants who are overtly healthy as determined by medicalevaluation 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:

  1. Have a clinical diagnosis of chronic AD (also known as atopic eczema) forapproximately 1 year prior to Day 1 and have the diagnosis of AD confirmed.

  2. 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 studyintervention). OR Have a documented reason why topical treatments areconsidered medically inappropriate within the last year.

  3. Have moderate to severe AD (defined as having an affected BSA (captured as partof EASI) ≥10%, IGA ≥3, and EASI ≥12 at both the screening and baseline visits).

  4. Have an otherwise healthy medical evaluation (other than signs and symptoms ofAD) 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).

Exclusion

Exclusion Criteria:

  • Have a history of systemic infection requiring hospitalization and parenteralantimicrobial therapy, any lymphoproliferative disorder, malignancies.

  • Evidence or history of clinically significant hematological, renal, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological,immunological/rheumatological disorder.

  • Have undergone significant trauma or major surgery within 1 month of the first doseof study intervention.

  • Evidence of active, latent, or inadequately treated infection with Mycobacteriumtuberculosis (TB) as defined by both of the following:

  1. A positive QuantiFERON-TB Gold In-tube or equivalent test.

  2. History of either untreated or inadequately treated latent or active TBinfection, or current treatment for the same.

Part 2 Only

  • Currently have active forms of other inflammatory skin diseases

  • Have history of or current evidence of skin conditions at the time of Day 1 thatwould interfere with evaluation of atopic dermatitis or response to treatment. Haveactive chronic or acute skin infection requiring treatment with systemicantibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2weeks prior to Day 1, or superficial skin infections within 1 week prior to Day 1.

  • Score of >5 on the Fitzpatrick Skin Type Assessment.

  • History of anaphylaxis with the following exceptions: participants with sensitivityand/or anaphylaxis only to a single, avoidable allergen (eg, aspirin, penicillin,sulfa drugs, nonsteroidal anti-inflammatory drugs [NSAIDs], peanuts) may beenrolled, if in the opinion of the investigator, the participant is aware of thehypersensitivity and avoids the problematic allergen. Participants must carryappropriate treatment for anaphylaxis and must know how to manage anaphylacticreactions.

  • Any investigational or experimental therapy taken or procedure performed for AD,psoriasis, psoriatic arthritis, rheumatoid arthritis or other inflammatory diseasesin the previous 1 year should be discussed with the Pfizer Medical Monitor (ordesignee).

Study Design

Total Participants: 111
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
November 05, 2024
Estimated Completion Date:
June 02, 2027

Study Description

This is a first-in-human (FIH) study of PF-07832837 that will be conducted in 2 parts: Part 1 will be conducted in healthy adult participants and Part 2 will be conducted in adult participants with moderate to severe AD.

Part 1 is within-cohort randomized, participant- and investigator-blind, sponsor-open, placebo-controlled investigation of the safety, tolerability, PK, and immunogenicity following single and multiple ascending doses of PF-07832837 in healthy participants. Part 1 may also include a cohort of Japanese healthy adult participants to provide safety, tolerability, and PK data in Japanese population to enable the inclusion of Japanese participants in future clinical trials.

Part 2 is a randomized, participant- and investigator-blind, sponsor-open, placebo-controlled study to investigate the safety, tolerability, PK, and pharmacodynamics (including clinical effects) of PF-07832837 in participants with moderate to severe AD. Part 2 will consist of cohorts of participants with moderate to severe AD. A total of approximately 28 participants will receive either active PF-07832837 or placebo.

Connect with a study center

  • Anaheim Clinical Trials, LLC

    Anaheim, California 92801
    United States

    Active - Recruiting

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