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 ]

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]).


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