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Study Complete
Sponsor ID
20110236

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

Sponsor ID
20110236
Clinicaltrials.gov ID
NCT02170337
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 1
Product
AMG 282
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
41
Additional Study Details

Protocol Summary

Primary Outcome Measures

Safety and tolerability

Timeframe: 169 days

Immunogenicity

Timeframe: 169 days

Secondary Outcome Measures

Pharmacokinetic profile of AMG 282

Timeframe: 169 days

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
South Miami, FL, United States, 33143
Status
Recruiting
Location
Research Site
Houston, TX, United States, 77030
Status
Recruiting
Location
Research Site
Aurora, CO, United States, 80045
Status
Recruiting
Location
Research Site
Santa Monica, CA, United States, 90404
Status
Recruiting
Study Info
Age
18 - 65 Years
Condition
  • Sinusitis
    • Sex
    All
    Trial Dates
    Jul 2014 - May 2016
    Inclusion and Exclusion 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) 24h for treatment of asthma, within 3 months prior to screening or are on a dose of greater than 1000 μg fluticasone.