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A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous rhuMAb Beta7 Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Ulcerative Colitis
This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Anniston, Alabama, United States
San Francisco, California, United States
Gainesville, Florida, United States
Atlanta, Georgia, United States
Lexington, Kentucky, United States
Rochester, Minnesota, United States
Great Neck, New York, United States
Chapel Hill, North Carolina, United States
Leuven, Belgium
Calgary, Alberta, Canada
Start Date
September 1, 2008
Primary Completion Date
September 1, 2011
Completion Date
September 1, 2012
Last Updated
November 2, 2016
48
ACTUAL participants
placebo
DRUG
rhuMAb Beta7
DRUG
Lead Sponsor
Genentech, Inc.
NCT07271069
NCT06975722
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07185009