RecruitingPhase 1interventionalRules rewrite

Phase 1: testing PF-07832837 for Healthy Participants

The purpose of the study is to measure 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 registry: https://clinicaltrials.gov/study/NCT06564389 · Pfizer · enrollment listed as 119

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are PF-07832837, or Placebo. The registry lists allocation as randomized. The purpose of the study is to measure 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.

They plan to enroll about 119 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: PF-07832837, Placebo

Primary outcome (registry wording): Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and serious adverse events (SAEs) Following single ascending doses (SAD)

Who it is for (from inclusion criteria)

Ages 18 Years to 70 Years
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
body-mass index (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
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)

Who the registry excludes

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
Currently have active forms of other inflammatory skin diseases

Public study contact (from the registry)

Pfizer CT.gov Call Center

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

8 listed

Anaheim Clinical Trials, LLC — Anaheim, California (recruiting)
TCR Medical Corporation — San Diego, California (recruiting)
Miami Dermatology and Laser Research — Miami, Florida (recruiting)
Revival Research Institute, LLC — Troy, Michigan (recruiting)
Paddington Testing Company — Philadelphia, Pennsylvania (recruiting)

+ 3 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06564389 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06564389?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06564389?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary