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Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis
Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis
CompletedPhase 1
Sponsor: Pfizer
Conditions: Healthy, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis
Interventions: PF-06817024, Placebo for PF-06817024, PF-06817024, Placebo for PF-06817024, PF-06817024
Countries: United States
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 overview
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Eligibility criteria
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)
Locations (20)
- Sacramento, California, United States
- Sacramento, California, United States
- Sacramento, California, United States
- New Haven, Connecticut, United States
- Shelton, Connecticut, United States
- Tampa, Florida, United States
- Indianapolis, Indiana, United States
- Indianapolis, Indiana, United States
- Plainfield, Indiana, United States
- Edina, Minnesota, United States
- Minneapolis, Minnesota, United States
- Minneapolis, Minnesota, United States
- Saint Paul, Minnesota, United States
- Berlin, New Jersey, United States
- Raleigh, North Carolina, United States
- Tulsa, Oklahoma, United States
- Rapid City, South Dakota, United States
- San Antonio, Texas, United States
- San Antonio, Texas, United States
- Norfolk, Virginia, United States