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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

Last updated on March 28, 2020

FOR MORE INFORMATION
Study Location
UC Davis Dermatology
Sacramento, California, 95816 United States
Contact
1-800-254-6398
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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)

NCT02743871
Pfizer
Active, not recruiting
Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis

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Descriptive Information
Brief Title  ICMJE Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis
Official Title  ICMJE 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
Brief 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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy
  • Chronic Rhinosinusitis With Nasal Polyps
  • Atopic Dermatitis
Intervention  ICMJE
  • Biological: PF-06817024
    Subjects will be given one dose of PF-06817024 intravenously
  • Other: Placebo for PF-06817024
    Subjects will be given one dose of placebo for PF-06817024 intravenously
  • Biological: PF-06817024
    Subjects will be given one dose of PF-06817024 subcutaneously
  • Other: Placebo for PF-06817024
    Subjects will be given one dose of placebo for PF-06817024 subcutaneously
  • Biological: PF-06817024
    Subjects will be given two doses of PF-06817024 intravenously
  • Other: Placebo for PF-06817024
    Subjects will be given two doses of PF-06817024 intravenously
  • Biological: PF-06817024
    Subjects will be given 2 doses intravenously
  • Other: Placebo for PF-06817024
    Subjects will be given 2 doses intravenously
  • Biological: PF-06817024
    Subjects will be given doses of PF-06817024 intravenously
  • Other: Placebo for PF-06817024
    Subjects will be given doses of Placebo intravenously
Study Arms  ICMJE
  • Experimental: Cohort 1
    10 mg of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 2
    30 mg of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 3
    100 mg of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 4
    300 mg of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 5
    1000 mg of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 6
    2000 mg of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 7
    30 mg subcutaneous dose of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 8
    300 mg of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 9
    IV dose to be determined of PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 10
    PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 11
    PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 12
    PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
  • Experimental: Cohort 13
    PF-06817024 or placebo
    Interventions:
    • Biological: PF-06817024
    • Other: Placebo for PF-06817024
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 3, 2019)
97
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2016)
110
Estimated Study Completion Date  ICMJE February 14, 2021
Estimated Primary Completion Date February 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02743871
Other Study ID Numbers  ICMJE C0341001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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