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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Chronic Rhinosinusitis With Nasal Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AMG 282

AMG 282 administered as subcutaneous and intravenous doses.

Group Type EXPERIMENTAL

AMG 282

Intervention Type DRUG

AMG 282 is for the treatment of subjects with chronic rhinosinusitis with nasal polyps

Placebo

No active drug

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Contains no active drug

Interventions

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AMG 282

AMG 282 is for the treatment of subjects with chronic rhinosinusitis with nasal polyps

Intervention Type DRUG

Placebo

Contains no active drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

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):

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes