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 |
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Conditions: | Sinusitis |
Therapuetic Areas: | Otolaryngology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/21/2016 |
Start Date: | July 2014 |
End Date: | May 2016 |
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
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) = 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.
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