A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects with chronic rhinosinusitis with nasal polyps
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
41
Research Site
Santa Monica, California, United States
Research Site
Aurora, Colorado, United States
Research Site
South Miami, Florida, United States
Research Site
Houston, Texas, United States
Safety and tolerability
Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECGs)
Time frame: 169 days
Immunogenicity
Subject incidence of anti-AMG 282 antibodies
Time frame: 169 days
Pharmacokinetic profile of AMG 282
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 \[Cmax\]).
Time frame: 169 days
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