Back to resultsA Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps
Primary Purpose
Chronic Rhinosinusitis With Nasal Polyps
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AMG 282
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis With Nasal Polyps
Eligibility Criteria
Healthy Volunteers:
Inclusion Criteria:
- Healthy males and females witha BMI between 18.0 and 32.0 kg/m2, inclusive
Exclusion Criteria:
- subject with evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with study evaluation, procedures, or completion.
Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP):
Inclusion Criteria:
- diagnosis of CRSwNP (inflammation of the nose and paranasal sinuses characterized in adults by 2 or more symptoms, 1 of which should be either nasal blockage or nasal discharge and/or facial pain and/or reduced smell for greater than 12 weeks)
- bilateral nasal polyps of grade 3 or 4
Exclusion Criteria:
- Forced Expiratory Volume (FEV1) </= 70%
- Asthma exacerbation requiring systemic corticosteroid treatment or hospitalization for > 24h for treatment of asthma, within 3 months prior to screening or are on a dose of greater than 1000 μg fluticasone.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AMG 282
Placebo
Arm Description
AMG 282 administered as subcutaneous and intravenous doses.
No active drug
Outcomes
Primary Outcome Measures
Safety and tolerability
Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECGs)
Immunogenicity
Subject incidence of anti-AMG 282 antibodies
Secondary Outcome Measures
Pharmacokinetic profile of AMG 282
Serum concentrations and derived PK parameters (eg, time to maximum concentration [tmax], area under the concentration-time curve over the dosing interval τ [AUCτ] after the first and last dose, and maximum observed concentration [Cmax]).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02170337
Brief Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps
Official Title
A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects with chronic rhinosinusitis with nasal polyps
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis With Nasal Polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMG 282
Arm Type
Experimental
Arm Description
AMG 282 administered as subcutaneous and intravenous doses.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
No active drug
Intervention Type
Drug
Intervention Name(s)
AMG 282
Intervention Description
AMG 282 is for the treatment of subjects with chronic rhinosinusitis with nasal polyps
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Contains no active drug
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECGs)
Time Frame
169 days
Title
Immunogenicity
Description
Subject incidence of anti-AMG 282 antibodies
Time Frame
169 days
Secondary Outcome Measure Information:
Title
Pharmacokinetic profile of AMG 282
Description
Serum concentrations and derived PK parameters (eg, time to maximum concentration [tmax], area under the concentration-time curve over the dosing interval τ [AUCτ] after the first and last dose, and maximum observed concentration [Cmax]).
Time Frame
169 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Healthy Volunteers:
Inclusion Criteria:
Healthy males and females witha BMI between 18.0 and 32.0 kg/m2, inclusive
Exclusion Criteria:
subject with evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with study evaluation, procedures, or completion.
Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP):
Inclusion Criteria:
diagnosis of CRSwNP (inflammation of the nose and paranasal sinuses characterized in adults by 2 or more symptoms, 1 of which should be either nasal blockage or nasal discharge and/or facial pain and/or reduced smell for greater than 12 weeks)
bilateral nasal polyps of grade 3 or 4
Exclusion Criteria:
Forced Expiratory Volume (FEV1) </= 70%
Asthma exacerbation requiring systemic corticosteroid treatment or hospitalization for > 24h for treatment of asthma, within 3 months prior to screening or are on a dose of greater than 1000 μg fluticasone.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Research Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps
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