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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT02743871•Pfizer

View on ClinicalTrials.gov

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

Detailed 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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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)

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

Key Dates

Start Date

April 27, 2016

Primary Completion Date

March 9, 2021

Completion Date

March 9, 2021

Last Updated

May 19, 2022

Enrollment

ACTUAL participants

Conditions

HealthyChronic Rhinosinusitis With Nasal PolypsAtopic Dermatitis

Interventions

PF-06817024

BIOLOGICAL

Placebo for PF-06817024

OTHER

PF-06817024

BIOLOGICAL

Placebo for PF-06817024

OTHER

PF-06817024

BIOLOGICAL

Placebo for PF-06817024

OTHER

PF-06817024

BIOLOGICAL

Placebo for PF-06817024

OTHER

PF-06817024

BIOLOGICAL

Placebo for PF-06817024

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 19, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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