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

NCT06564389 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: C4991001NCT06564389
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (11)

• 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.

  Baseline up to Day 35

• 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.

  Baseline up to Day 35

• 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.

  Baseline up to Day 35

• 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.

  Baseline up to Day 35

• 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.

  Day 1

• 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.

  Baseline up to Day 50

• 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.

  Baseline up to Day 50

• 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.

  Baseline up to Day 50

• 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.

  Baseline up to Day 80

• 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.

  Baseline up to Day 80

• 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.

  Baseline up to Day 78

Secondary Outcomes (9)

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

  Day 1 to Day 35

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

  Day 1 to Day 35

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

  Day 1 to Day 35

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

  Day 1 to Day 35

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

  Day 1 to Day 35

Study Arms (2)

PF-07832837

EXPERIMENTAL

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

Drug: PF-07832837

placebo

PLACEBO COMPARATOR

single or multiple doses of placebo

Other: Placebo

Interventions

Placebo OTHER

placebo

placebo

PF-07832837 DRUG

escalated doses of PF-07832837

PF-07832837

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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.
• 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.
• 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).

You may not qualify if:

• 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:
• A positive QuantiFERON-TB Gold In-tube or equivalent test.
• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

RECRUITING

Miami Dermatology and Laser Research

Miami, Florida, 33133, United States

NOT YET RECRUITING

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

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): June 2, 2027
• Study Completion (Estimated): June 2, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)