A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps

Completed · Phase 1 · Has a placebo group

Conditions studied: Chronic Rhinosinusitis With Nasal Polyps

In brief

A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects with chronic rhinosinusitis with nasal polyps

Key facts

Study ID: NCT02170337
Run by: Amgen
People needed: 41
Starts: 2014-07-01
Expected to finish: 2016-05-01
Last updated by the study team: 2016-06-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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):
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.

Where it is running

Research Site — Santa Monica, California, United States
Research Site — Aurora, Colorado, United States
Research Site — South Miami, Florida, United States
Research Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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