To assess the safety and tolerability of multiple subcutaneous doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
43
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
Research Site
Glendale, California, United States
Research Site
Bridgeport, Connecticut, United States
Research Site
Danbury, Connecticut, United States
Research Site
Miami, Florida, United States
To assess the number of adverse events per subject, after multiple subcutaneous doses of AMG 181 in in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
Time frame: 40 Weeks
To measure the area under the plasma concentration curve versus time of drug AMG 181.
Time frame: 29 Weeks
To assess receptor saturation percentages relative to baseline after multiple doses of AMG 181.
Time frame: 29 Weeks
To evaluate changes in peripheral blood T lymphocyte subsets counts relative to baseline after multiple doses of AMG 181.
Time frame: 29 weeks
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Research Site
Duncansville, Pennsylvania, United States
Research Site
Herston, Queensland, Australia
Research Site
Adelaide, South Australia, Australia
Research Site
Prahran, Victoria, Australia