Study Complete
Sponsor ID
20101147
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 811 in subjects with Psoriasis
Study Details
The purpose of this study is to assess the safety, tolerability, immunogenicity, and clinical effects of AMG 811 following single subcutaneous dose administration in subjects with moderate to severe psoriasis.
Protocol Summary
Primary Outcome Measures
Evaluate the number of adverse events per subject, including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 811
Timeframe: 16 weeks
Secondary Outcome Measures
Evaluate the efficacy of AMG 811 as measured by the following: the proportion of subjects with a PASI 50, 75 and 90
Timeframe: 16 weeks
Measure the area under the serum concentration curve versus time of AMG 811 after a single dose administration in subjects with moderate to severe psoriasis
Timeframe: 16 weeks
Measure the peak serum concentration (Cmax) of AMG 811 after a single dose administration in subjects with moderate to severe psoriasis
Timeframe: 16 weeks
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Herston, QLD, Australia, 4006
Status
Recruiting
Location
Research Site
Nedlands, WA, Australia, 6009
Status
Recruiting
Location
Research Site
Christchurch, New Zealand, 8011
Status
Recruiting
Location
Research Site
Grafton, Auckland, New Zealand, 1010
Status
Recruiting