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 |
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
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
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
6565 S. Yale Ave.
Tulsa, Oklahoma 74136
Tulsa, Oklahoma 74136
918-392-4550
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