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



Status:Active, not recruiting
Conditions:Healthy Studies, Psoriasis, Sinusitis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Otolaryngology, Other
Healthy:No
Age Range:18 - 75
Updated:3/17/2019
Start Date:April 27, 2016
End Date:February 14, 2021

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A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SINGLE AND/OR MULTIPLE INTRAVENOUS AND/OR SUBCUTANEOUS DOSES OF PF-06817024 IN HEALTHY SUBJECTS WHO MAY BE MILDLY ATOPIC, SUBJECTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPS, AND SUBJECTS WITH MODERATE-SEVERE ATOPIC DERMATITIS

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

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

Inclusion Criteria

- Healthy male subjects, healthy female subjects of non-childbearing potential, 18-55
years of age (Part 1)

- Male subjects, female subjects of non-childbearing potential, female subjects of
childbearing potential with documented bilateral tubal ligation (tubes tied) or
bilateral salpingectomy (tubes removed), 18-65 years of age, and 2 of the following
symptoms: nasal congestion/obstruction, nasal discharge, face pain/pressure,or
reduction/loss of smell (Part 2)

- Male or female subjects between the ages of 18 and 75 years, inclusive with
moderate-to-severe Atopic Dermatitis, agree to avoid prolonged exposure to the sun and
not to use tanning booths, sun lamps, or other ultraviolet light sources during the
study (Part 3)

Exclusion Criteria:

- Clinically significant diseases (cardiac, psychiatric, autoimmune, renal, etc.),
positive urine drug test, fever within 7 days of dosing, active infections within 28
days of dosing (Part 1 and 2 and 3)

- History of allergic reaction to topical lidocaine, nasal surgery within 6 months (Part
2)

- Exposure to live or attenuated vaccines, have skin conditions other than Atopic
Dermatitis, use of JAK inhibitors and biologics (Part 3)
We found this trial at
20
sites
Saint Paul, Minnesota 55114
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Saint Paul, MN
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
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San Antonio, TX
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6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
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Tulsa, OK
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Berlin, New Jersey
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Berlin, NJ
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6545 France Avenue South
Edina, Minnesota 55435
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Edina, MN
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Indianapolis, Indiana 46256
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Indianapolis, IN
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Indianapolis, Indiana 46256
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Indianapolis, IN
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Minneapolis, Minnesota 55402
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Minneapolis, MN
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2211 Park Avenue
Minneapolis, Minnesota 55404
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Minneapolis, MN
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New Haven, Connecticut 06511
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New Haven, CT
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Norfolk, Virginia 23507
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Norfolk, VA
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Plainfield, Indiana 46168
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Plainfield, IN
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3100 Duraleigh Road
Raleigh, North Carolina 27612
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Raleigh, NC
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Rapid City, South Dakota 57702
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Rapid City, SD
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Sacramento, California 95864
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Sacramento, CA
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Sacramento, California 95817
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Sacramento, CA
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2315 Stockton Blvd
Sacramento, California 95817
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Sacramento, CA
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San Antonio, Texas 78229
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San Antonio, TX
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4 Corporate Drive
Shelton, Connecticut 06484
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Shelton, CT
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Tampa, Florida 33624
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Tampa, FL
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