Trials / Completed
CompletedNCT00694980
A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | placebo | Intravenous and subcutaneous escalating doses |
| DRUG | rhuMAb Beta7 | Intravenous and subcutaneous escalating doses |
Timeline
- Start date
- 2008-09-01
- Primary completion
- 2011-09-01
- Completion
- 2012-09-01
- First posted
- 2008-06-11
- Last updated
- 2016-11-02
Locations
30 sites across 6 countries: United States, Belgium, Canada, Germany, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT00694980. Inclusion in this directory is not an endorsement.