Recruiting
Phase 1

PF-07832837

Sponsor:

Pfizer

Code:

NCT06564389

Conditions

Healthy Participants

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

PF-07832837

Placebo

Study Details

Brief 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

Conditions

Healthy Participants

Atopic Dermatitis

Study ID

NCT06564389

Start date

Nov 5, 2024

Status verified date

Jul, 2026

Completion date

Jun 2, 2027

Anticipated

Primary completion date

Jun 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.
  • 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:

1. Have a clinical diagnosis of chronic AD (also known as atopic eczema) for at least 1 year prior to Day 1 and have the diagnosis of AD confirmed by photographs (at screening) and diagnostic criteria for AD.
2. Either an inadequate response to treatment with standard of care treatments (excluding systemic immunosuppressant treatments) consistent with AD treatment guidelines (for at least 4 consecutive weeks within 6 to 12 months (depending on time since initial diagnosis) of the first dose of the study intervention. OR Have a documented reason why topical treatments are considered medically inappropriate within the last year.
3. 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).
4. 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.

Controlled comorbid diseases are acceptable so long as they do not require administration of prohibited medications. This includes participants with mild or moderate asthma that is well-controlled (not requiring high dose inhaled corticosteroids, systemic \[oral or parenteral\] corticosteroids, or biologic asthma treatments).

Exclusion Criteria:

  • Have a history of systemic infection requiring hospitalization and parenteral antimicrobial 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 dose of study intervention.
  • Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (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 TB infection, 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 that would interfere with evaluation of atopic dermatitis or response to treatment. Have active chronic or acute skin infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks 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 sensitivity and/or anaphylaxis only to a single, avoidable allergen (eg, aspirin, penicillin, sulfa drugs, nonsteroidal anti-inflammatory drugs \[NSAIDs\], peanuts) may be enrolled, if in the opinion of the investigator, the participant is aware of the hypersensitivity and avoids the problematic allergen. Participants must carry appropriate treatment for anaphylaxis and must know how to manage anaphylactic reactions.
  • Any investigational or experimental therapy taken or procedure performed for AD, psoriasis, psoriatic arthritis, rheumatoid arthritis or other inflammatory diseases in the previous 1 year should be discussed with the Pfizer Medical Monitor (or designee).

Study Design

Enrollment

119 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PF-07832837

single or multiple doses of PF-07832837 at ascending dose levels

placebo comparator: placebo

single or multiple doses of placebo

Interventions

PF-07832837

escalated doses of PF-07832837

Placebo

placebo

Primary outcome measure

  • Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and serious adverse events (SAEs) Following single ascending doses (SAD) [ Time Frame: Baseline up to Day 35 ]
  • Number of Participants with Clinically significant Laboratory Abnormalities Following SAD [ Time Frame: Baseline up to Day 35 ]
  • Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings Following SAD [ Time Frame: Baseline up to Day 35 ]
  • Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following SAD [ Time Frame: Baseline up to Day 35 ]
  • Number of Participants with Clinically Significant Change from Baseline in Cardiac Telemetry Findings Following SAD [ Time Frame: Day 1 ]
  • Number of Participants With Treatment Emergent Treatment-Related AEs and SAEs Following multiple ascending doses (MAD) [ Time Frame: Baseline up to Day 50 ]
  • Number of Participants with Clinically significant Laboratory Abnormalities Following MAD [ Time Frame: Baseline up to Day 50 ]
  • Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings Following MAD [ Time Frame: Baseline up to Day 50 ]
  • Number of Participants With Treatment Emergent Treatment-Related AEs and SAEs in participants with atopic dermatitis (AD) [ Time Frame: Baseline up to Day 80 ]
  • Number of Participants with Clinically significant Laboratory Abnormalities in participants with AD [ Time Frame: Baseline up to Day 80 ]
  • Number of Participants with Clinically Significant Change from Baseline in Vital Signs in participants with AD [ Time Frame: Baseline up to Day 78 ]

Central Contacts and Locations

Central contacts

Locations

Anaheim Clinical Trials, LLC

Recruiting

Anaheim, California, United States, 92801

TCR Medical Corporation

Recruiting

San Diego, California, United States, 92123

Miami Dermatology and Laser Research

Recruiting

Miami, Florida, United States, 33133

Revival Research Institute, LLC

Recruiting

Troy, Michigan, United States, 48084

Paddington Testing Company

Recruiting

Philadelphia, Pennsylvania, United States, 19103

More Information

Sponsor

Pfizer

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • healthy
  • atopic dermatitis
  • first in human
  • monoclonal antibody
  • anti-inflammatory
  • pharmacokinetics
  • pharmacodynamics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Pfizer on 2026-07-22.