To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate ulcerative colitis (UC)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Ten escalating dose levels of AMG 181 administered as single dose SC or IV, in healthy volunteers and SC subjects with mild-to-moderate ulcerative colitis.
Research Site
Glendale, California, United States
Research Site
Danbury, Connecticut, United States
Research Site
Plymouth, Minnesota, United States
Research Site
Duncansville, Pennsylvania, United States
To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate ulcerative colitis (UC)
Time frame: Through study completion
To characterize the pharmacokinetics (PK) of ascending single doses of AMG 181
Time frame: Through study completion
To characterize the pharmacodynamic (PD) effects of AMG 181 on receptor occupancy and on cell counts in selected lymphocyte subset populations
Time frame: Through study completion
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Research Site
Herston, Queensland, Australia
Research Site
Adelaide, South Australia, Australia
Research Site
Prahran, Victoria, Australia
Research Site
Nedlands, Western Australia, Australia
Research Site
Auckland, New Zealand
Research Site
Christchurch, New Zealand