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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Keep this study
Lead
Amgen
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy Volunteers:
Healthy males and females witha BMI between 18.0 and 32.0 kg/m2, inclusive
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
You may not be 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):
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.
Clareo Health | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps
