Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
| Status: | Archived |
|---|---|
| Conditions: | Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | November 2009 |
| End Date: | April 2010 |
A Phase I Double-blind, Randomized, Comparator-controlled Study of the Safety and Tolerability of N-acetylcysteine Plus Mesalamine Enema in Subjects With Left-sided Ulcerative Colitis
This Phase I study will be a closely monitored trial of a small number of subjects to
establish, preliminarily, the tolerability and safety of two ALTH12 enema formulations:
ALTH12-1:4 and ALTH12-2:4. The study will be conducted in two parts. The first part will be
the assessment of the safety and tolerability of a single dose of ALTH12-1:4 or the
comparator, mesalamine (4.0g 5-ASA) followed by an assessment of repeated administrations of
study drug (ALTH12-1:4 or comparator) for 6 weeks. The second part will be the same
assessment for ALTH12-2:4. Three subjects will be enrolled in each cohort: 2 to receive
ALTH12 enema therapy and 1 subject to receive comparator enema therapy. A total of up to 9
patients will be enrolled in this study, allowing for up to 3 replacement or additional
patients.
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