Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis
Status and phase
Completed
Phase 1
Conditions
Atopic Dermatitis
Healthy
Chronic Rhinosinusitis With Nasal Polyps
Treatments
Other: Placebo for PF-06817024
Biological: PF-06817024
Details and patient eligibility
About
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
Full 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
Enrollment
97 patients
Sex
All
Ages
18 to 75 years old
Volunteers
Accepts Healthy Volunteers
Inclusion and exclusion 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)
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Sequential Assignment
Masking
Quadruple Blind
97 participants in 13 patient groups
Cohort 1
Experimental group
Description:
10 mg of PF-06817024 or placebo
Treatment:
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Cohort 2
Experimental group
Description:
30 mg of PF-06817024 or placebo
Treatment:
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Cohort 3
Experimental group
Description:
100 mg of PF-06817024 or placebo
Treatment:
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Cohort 4
Experimental group
Description:
300 mg of PF-06817024 or placebo
Treatment:
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Cohort 5
Experimental group
Description:
1000 mg of PF-06817024 or placebo
Treatment:
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Cohort 6
Experimental group
Description:
2000 mg of PF-06817024 or placebo
Treatment:
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Cohort 7
Experimental group
Description:
30 mg subcutaneous dose of PF-06817024 or placebo
Treatment:
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Cohort 8
Experimental group
Description:
300 mg of PF-06817024 or placebo
Treatment:
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Cohort 9
Experimental group
Description:
IV dose to be determined of PF-06817024 or placebo
Treatment:
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Cohort 10
Experimental group
Description:
PF-06817024 or placebo
Treatment:
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Cohort 11
Experimental group
Description:
PF-06817024 or placebo
Treatment:
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Cohort 12
Experimental group
Description:
PF-06817024 or placebo
Treatment:
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Cohort 13
Experimental group
Description:
PF-06817024 or placebo
Treatment:
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Other: Placebo for PF-06817024
Biological: PF-06817024
Trial contacts and locations
20
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Data sourced from clinicaltrials.gov
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