RECRUITING

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

Conditions

Healthy Participants Atopic Dermatitis healthy first in human monoclonal antibody anti-inflammatory pharmacokinetics pharmacodynamics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-11-05

Study Completion:2027-04-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06564389

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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: 1. 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. 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 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.	* 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. * 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).

Inclusion Criteria

Exclusion 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. 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:
1. 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.
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 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.

* 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.
* 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).

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center

STUDY_DIRECTOR

Pfizer

Study Locations (Sites)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801

United States

Collaborators and Investigators

Sponsor: Pfizer

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-05

Study Completion Date2027-04-15

Study Record Updates

Study Start Date2024-11-05

Study Completion Date2027-04-15

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Healthy Participants
Atopic Dermatitis