Overview

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:
Completed
Trial end date:
2016-05-01
Target enrollment:
0
Participant gender:
All
Summary
A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects with chronic rhinosinusitis with nasal polyps
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Amgen
Criteria
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.