Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis

Last updated: February 28, 2022
Sponsor: Pfizer
Overall Status: Completed

Phase

1

Condition

Atopic Dermatitis

Nasal Obstruction

Rash

Treatment

N/A

Clinical Study ID

NCT02743871
C0341001
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06817024 in healthy volunteers, in participants with chronic rhinosinusitis, with nasal polyps and in participants with moderate-to-severe Atopic Dermatitis

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Healthy male subjects, healthy female subjects of non-childbearing potential, 18-55years of age (Part 1)
  • Male subjects, female subjects of non-childbearing potential, female subjects ofchildbearing potential with documented bilateral tubal ligation (tubes tied) orbilateral salpingectomy (tubes removed), 18-65 years of age, and 2 of the followingsymptoms: nasal congestion/obstruction, nasal discharge, face pain/pressure,orreduction/loss of smell (Part 2)
  • Male or female subjects between the ages of 18 and 75 years, inclusive withmoderate-to-severe Atopic Dermatitis, agree to avoid prolonged exposure to the sun andnot to use tanning booths, sun lamps, or other ultraviolet light sources during thestudy (Part 3)

Exclusion

Exclusion Criteria:

  • Clinically significant diseases (cardiac, psychiatric, autoimmune, renal, etc.),positive urine drug test, fever within 7 days of dosing, active infections within 28days of dosing (Part 1 and 2 and 3)
  • History of allergic reaction to topical lidocaine, nasal surgery within 6 months (Part
  • Exposure to live or attenuated vaccines, have skin conditions other than AtopicDermatitis, use of JAK inhibitors and biologics (Part 3)

Study Design

Total Participants: 97
Study Start date:
April 27, 2016
Estimated Completion Date:
March 09, 2021

Study Description

The purpose of the study for Part 1 is to evaluate the safety and tolerability of PF-06817024 in healthy subjects.

The purpose of the study for Part 2 is to evaluate the safety and tolerability of PF-06817024 in patients with chronic rhinosinusitis with nasal polyps.

The purpose of the study for Part 3 is to evaluate the safety and tolerability of PF-06817024 in patients with moderate-to-severe Atopic Dermatitis

Connect with a study center

  • UC Davis CTSC Clinical Research Center

    Sacramento, California 95817
    United States

    Site Not Available

  • UC Davis Dermatology

    Sacramento, California 95816
    United States

    Site Not Available

  • UC Davis Health

    Sacramento, California 95817
    United States

    Site Not Available

  • New Haven Clinical Research Unit

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Dermatology Physicians of Connecticut

    Shelton, Connecticut 06484
    United States

    Site Not Available

  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • Dawes Fretzin Dermatology Group, LLC

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • The Indiana Clinical Trials Center

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • CDI - Blaine

    Blaine, Minnesota 55449
    United States

    Site Not Available

  • CDI - Burnsville

    Burnsville, Minnesota 55337
    United States

    Site Not Available

  • CDI - Coon Rapids

    Coon Rapids, Minnesota 55433
    United States

    Site Not Available

  • CDI - Eagan

    Eagan, Minnesota 55121
    United States

    Site Not Available

  • CDI - Eden Prairie

    Eden Prairie, Minnesota 55344
    United States

    Site Not Available

  • Academic Dermatology

    Edina, Minnesota 55435
    United States

    Site Not Available

  • CDI - Lakeville

    Lakeville, Minnesota 55044
    United States

    Site Not Available

  • CDI - Maple Grove

    Maple Grove, Minnesota 55369
    United States

    Site Not Available

  • CDI - Maplewood

    Maplewood, Minnesota 55109
    United States

    Site Not Available

  • CDI - Mendota Heights

    Mendota Heights, Minnesota 55118
    United States

    Site Not Available

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota 55402
    United States

    Site Not Available

  • Ear, Nose & Throat Specialty Care of Minnesota, P.A.

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • CDI - North St. Paul

    N. Saint Paul, Minnesota 55109
    United States

    Site Not Available

  • CDI - Roseville

    Roseville, Minnesota 55113
    United States

    Site Not Available

  • CDI - St. Louis Park

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Prism Research, LLC

    Saint Paul, Minnesota 55114
    United States

    Site Not Available

  • Prism Research, LLC

    St. Paul, Minnesota 55114
    United States

    Site Not Available

  • CDI - West St. Paul

    W. Saint Paul, Minnesota 55118
    United States

    Site Not Available

  • CDI - Woodbury

    Woodbury, Minnesota 55125
    United States

    Site Not Available

  • Hassman Research Institute

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Carolina Phase 1 Research, LLC

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Vital Prospects Clinical Research Institute, PC

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Health Concepts

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • Lee Medical Associates, PA

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Progressive Clinical Research, PA

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia 23502
    United States

    Site Not Available

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