This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Intravenous and subcutaneous escalating doses
Intravenous and subcutaneous escalating doses
Unnamed facility
Anniston, Alabama, United States
Incidence and nature of laboratory abnormalities
Time frame: Through study completion or early study discontinuation
Incidence, nature, and severity of adverse events
Time frame: Through study completion or early study discontinuation
PK profile and parameters
Time frame: Through study completion or early study discontinuation
Incidence of antibodies directed against rhuMAb Beta7
Time frame: Through study completion or early study discontinuation
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Unnamed facility
San Francisco, California, United States
Unnamed facility
Gainesville, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Lexington, Kentucky, United States
Unnamed facility
Rochester, Minnesota, United States
Unnamed facility
Great Neck, New York, United States
Unnamed facility
Chapel Hill, North Carolina, United States
Unnamed facility
Leuven, Belgium
Unnamed facility
Calgary, Alberta, Canada
...and 20 more locations