Safety and Pharmacokinetics Study of HE3286 in Patients With Active, Mild-to-Moderate Ulcerative Colitis
NCT00628433 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2011-06-14
Summary
The purpose of this pilot, exploratory study is to evaluate the safety, tolerance, pharmacokinetics and potential activity of an investigational agent, HE3286, when administered orally, daily for 28 days to patients with mild-to-moderate ulcerative colitis.
Conditions
Interventions
- DRUG
-
Placebo
- DRUG
-
HE3286
daily for 28 days
Sponsors & Collaborators
-
Harbor Therapeutics
lead INDUSTRY
Principal Investigators
-
Dwight R Stickney, MD · Harbor Therapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-02-29
- Primary Completion
- 2009-05-31
- Completion
- 2009-05-31
Countries
- United States
Study Locations
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