A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps
Phase 1
Completed
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Interventions
- Drug: Placebo
- Registration Number
- NCT02170337
- Lead Sponsor
- Amgen
- Brief Summary
A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects with chronic rhinosinusitis with nasal polyps
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AMG 282 AMG 282 AMG 282 administered as subcutaneous and intravenous doses. Placebo Placebo No active drug
- Primary Outcome Measures
Name Time Method Immunogenicity 169 days Subject incidence of anti-AMG 282 antibodies
Safety and tolerability 169 days Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECGs)
- Secondary Outcome Measures
Name Time Method Pharmacokinetic profile of AMG 282 169 days Serum concentrations and derived PK parameters (eg, time to maximum concentration \[tmax\], area under the concentration-time curve over the dosing interval τ \[AUCτ\] after the first and last dose, and maximum observed concentration \[Cmax\]).
Trial Locations
- Locations (1)
Research Site
🇺🇸Houston, Texas, United States