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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT02743871

Run by

Pfizer

People needed

97

Starts

2016-04-27

Expected to finish

2021-03-09

Last updated by the study team

2022-05-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• UC Davis Dermatology — Sacramento, California, United States
• UC Davis CTSC Clinical Research Center — Sacramento, California, United States
• UC Davis Health — Sacramento, California, United States
• New Haven Clinical Research Unit — New Haven, Connecticut, United States
• Dermatology Physicians of Connecticut — Shelton, Connecticut, United States
• ForCare Clinical Research — Tampa, Florida, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Dawes Fretzin Dermatology Group, LLC — Indianapolis, Indiana, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Academic Dermatology — Edina, Minnesota, United States
• Clinical Research Institute, Inc. — Minneapolis, Minnesota, United States
• Ear, Nose & Throat Specialty Care of Minnesota, P.A. — Minneapolis, Minnesota, United States
• Prism Research, LLC — Saint Paul, Minnesota, United States
• Hassman Research Institute — Berlin, New Jersey, United States
• Carolina Phase 1 Research, LLC — Raleigh, North Carolina, United States
• Vital Prospects Clinical Research Institute, PC — Tulsa, Oklahoma, United States
• Health Concepts — Rapid City, South Dakota, United States
• Lee Medical Associates, PA — San Antonio, Texas, United States
• Progressive Clinical Research, PA — San Antonio, Texas, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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