Terminated/Withdrawn
Sponsor ID
20090107
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects with Mild to Moderate Ulcerative Colitis
Study Details
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)
Protocol Summary
Primary Outcome Measures
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)
Timeframe: Through study completion
Secondary Outcome Measures
To characterize the pharmacokinetics (PK) of ascending single doses of AMG 181
Timeframe: Through study completion
To characterize the pharmacodynamic (PD) effects of AMG 181 on receptor occupancy and on cell counts in selected lymphocyte subset populations
Timeframe: Through study completion
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Prahran, VIC, Australia, 3004
Status
Recruiting
Location
Research Site
Adelaide, SA, Australia, 5000
Status
Recruiting
Location
Research Site
Herston, QLD, Australia, 4006
Status
Recruiting
Location
Research Site
Nedlands, WA, Australia, 6009
Status
Completed
Location
Research Site
Auckland, New Zealand, 1023
Status
Completed
Location
Research Site
Christchurch, New Zealand, 8011
Status
Completed
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