Study Complete
Sponsor ID
20090519
Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects
Study Details
The purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn’s disease (CD).
Protocol Summary
Primary Outcome Measures
Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139
Timeframe: 36 weeks
Secondary Outcome Measures
Characterization of the pharmacokinetic (PK) parameters (AUCtau, Cmax, tmax) for AMG 139 after multiple IV and SC dose administrations in healthy subjects and subjects with mild to severe CD
Timeframe: 36 weeks
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Prahran, VIC, Australia, 3181
Status
Recruiting
Location
Research Site
Adelaide, SA, Australia, 5000
Status
Recruiting
Location
Research Site
Oklahoma City, OK, United States, 73102
Status
Recruiting
Location
Research Site
Berlin, NJ, United States, 08009
Status
Recruiting
Location
Research Site
Richmond, VA, United States, 23291
Status
Completed
Location
Research Site
Stony Brook, NY, United States, 11794
Status
Completed
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