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



Status:Active, not recruiting
Conditions:Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:July 2014
End Date:May 2016

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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

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


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)
- 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.
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