Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis
Condition: Healthy; Chronic Rhinosinusitis With Nasal Polyps; Atopic Dermatitis
MeSH terms: Sinusitis; Nasal Polyps; Dermatitis, Atopic; Dermatitis; Eczema; Polyps
Intervention: PF-06817024; Placebo for PF-06817024; PF-06817024; Placebo for PF-06817024; PF-06817024; Placebo for PF-06817024; PF-06817024; Placebo for PF-06817024; PF-06817024; Placebo for PF-06817024
Intervention description: Subjects will be given one dose of PF-06817024 intravenously; Subjects will be given one dose of placebo for PF-06817024 intravenously; Subjects will be given one dose of PF-06817024 subcutaneously; Subjects will be given one dose of placebo for PF-06817024 subcutaneously; Subjects will be given two doses of PF-06817024 intravenously; Subjects will be given two doses of PF-06817024 intravenously; Subjects will be given 2 doses intravenously; Subjects will be given 2 doses intravenously; Subjects will be given doses of PF-06817024 intravenously; Subjects will be given doses of Placebo intravenously
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: FIH, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, Atopic Dermatitis, Chronic Rhinosinusitis, Nasal Polyps

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 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)