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RecruitingNCT06564389Updated Jul 22, 2026

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

A Phase 1 interventional study of PF-07832837 and Placebo in Healthy Participants and Atopic Dermatitis, sponsored by Pfizer. Recruiting at 5 sites in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
119
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

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

Read the detailed 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.

02

Conditions studied

  • Healthy Participants
  • Atopic Dermatitis

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Keywords

  • healthy
  • atopic dermatitis
  • first in human
  • monoclonal antibody
  • anti-inflammatory
  • pharmacokinetics
  • pharmacodynamics
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's planned enrollment of 119 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
119 participants (estimated)

Study arms

  • Experimental
    PF-07832837

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

    Drug: PF-07832837

  • Placebo comparator
    placebo

    single or multiple doses of placebo

    Other: Placebo

Interventions

  • DrugPF-07832837

    escalated doses of PF-07832837

  • OtherPlacebo

    placebo

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and serious adverse events (SAEs) Following single ascending doses (SAD)

    An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs.

    Time frame: Baseline up to Day 35

  2. Number of Participants with Clinically significant Laboratory Abnormalities Following SAD

    Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure.

    Time frame: Baseline up to Day 35

  3. Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings Following SAD

    Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, corrected QT (QTc) intervals and QRS complex. Clinically significant findings were determined by the investigator.

    Time frame: Baseline up to Day 35

  4. Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following SAD

    Vital signs included blood pressure, pulse rate, respiratory rate, oxygen saturation and oral temperature. Clinically significant findings were determined by the investigator.

    Time frame: Baseline up to Day 35

  5. Number of Participants with Clinically Significant Change from Baseline in Cardiac Telemetry Findings Following SAD

    Cardiac telemetry was collected in Part 1 SAD cohorts only. Number of participants with any cardiac telemetry abnormalities were reported in this outcome measure.

    Time frame: Day 1

  6. Number of Participants With Treatment Emergent Treatment-Related AEs and SAEs Following multiple ascending doses (MAD)

    An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs.

    Time frame: Baseline up to Day 50

  7. Number of Participants with Clinically significant Laboratory Abnormalities Following MAD

    Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure.

    Time frame: Baseline up to Day 50

  8. Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings Following MAD

    Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, corrected QT (QTc) intervals and QRS complex. Clinically significant findings were determined by the investigator.

    Time frame: Baseline up to Day 50

  9. Number of Participants With Treatment Emergent Treatment-Related AEs and SAEs in participants with atopic dermatitis (AD)

    An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs.

    Time frame: Baseline up to Day 80

  10. Number of Participants with Clinically significant Laboratory Abnormalities in participants with AD

    Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure.

    Time frame: Baseline up to Day 80

  11. Number of Participants with Clinically Significant Change from Baseline in Vital Signs in participants with AD

    Vital signs included blood pressure, pulse rate, respiratory rate, oxygen saturation and oral temperature. Clinically significant findings were determined by the investigator.

    Time frame: Baseline up to Day 78

Secondary outcomes

  1. Area Under the Curve From Time Zero to Last (AUClast) of PF-07832837 following SAD

    estimated by Linear/Log trapezoidal method

    Time frame: Day 1 to Day 35

  2. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07832837 following SAD

    AUClast + (Clast\*/kel), where Clast\* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis

    Time frame: Day 1 to Day 35

  3. Maximum Observed Serum Concentration (Cmax) of PF-07832837 following SAD

    Observed directly from data

    Time frame: Day 1 to Day 35

  4. Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07832837 following SAD

    Observed directly from data as time of first occurrence

    Time frame: Day 1 to Day 35

  5. Terminal serum elimination half life (t1/2) of PF-07832837 following SAD

    Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration time curve. Only those data points judged to describe the terminal log-linear decline will be used in the regression

    Time frame: Day 1 to Day 35

  6. Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of PF-07832837 following MAD

    Linear/log trapezoidal method

    Time frame: Day 1 to Day 22

  7. Maximum Observed Serum Concentration (Cmax) of PF-07832837 following MAD

    Observed directly from data

    Time frame: Day 1 to Day 22

  8. Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07832837 following MAD

    Observed directly from data as the time of first occurrence

    Time frame: Day 1 to Day 22

  9. Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 8

    EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

    Time frame: Baseline, Week 8

07

Study locations

5 of 5 sites recruiting
  • Anaheim Clinical Trials, LLC
    Anaheim, California 92801, United States
    Recruiting
  • TCR Medical Corporation
    San Diego, California 92123, United States
    Recruiting
  • Miami Dermatology and Laser Research
    Miami, Florida 33133, United States
    Recruiting
  • Revival Research Institute, LLC
    Troy, Michigan 48084, United States
    Recruiting
  • Paddington Testing Company
    Philadelphia, Pennsylvania 19103, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06564389
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Aug 21, 2024
Start date
Nov 5, 2024
Primary completion
Jun 2, 2027 (estimated)
Completion
Jun 2, 2027 (estimated)
Last update
Jul 22, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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