Clinical Trial: 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 Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects W
Brief Summary: A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects with chronic rhinosinusitis with nasal polyps
Detailed Summary:
Sponsor: Amgen
Current Primary Outcome:
- Safety and tolerability [ Time Frame: 169 days ]Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECGs)
- Immunogenicity [ Time Frame: 169 days ]Subject incidence of anti-AMG 282 antibodies
Original Primary Outcome: Same as current
Current Secondary Outcome: Pharmacokinetic profile of AMG 282 [ Time Frame: 169 days ]
Original Secondary Outcome: Same as current
Information By: Amgen
Dates:
Date Received: June 19, 2014
Date Started: July 2014
Date Completion:
Last Updated: May 30, 2016
Last Verified: May 2016