A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps
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
1 other identifier
interventional
41
1 country
4
Brief Summary
A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects with chronic rhinosinusitis with nasal polyps
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2014
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2014
CompletedFirst Posted
Study publicly available on registry
June 23, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJune 1, 2016
May 1, 2016
1.8 years
June 19, 2014
May 30, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Safety and tolerability
Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECGs)
169 days
Immunogenicity
Subject incidence of anti-AMG 282 antibodies
169 days
Secondary Outcomes (1)
Pharmacokinetic profile of AMG 282
169 days
Study Arms (2)
AMG 282
EXPERIMENTALAMG 282 administered as subcutaneous and intravenous doses.
Placebo
PLACEBO COMPARATORNo active drug
Interventions
Eligibility Criteria
You may qualify if:
- Healthy males and females witha BMI between 18.0 and 32.0 kg/m2, inclusive
You may not qualify if:
- 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):
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (4)
Research Site
Santa Monica, California, 90404, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
South Miami, Florida, 33143, United States
Research Site
Houston, Texas, 77030, United States
Related Links
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2014
First Posted
June 23, 2014
Study Start
July 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
June 1, 2016
Record last verified: 2016-05