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
Overview
- Phase
- Phase 1
- Intervention
- mesalamine
- Conditions
- Ulcerative Colitis
- Sponsor
- Altheus Therapeutics, Inc.
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- To determine the safety and tolerability of ALTH12 when given by intrarectal administration over 6 weeks to subjects with ulcerative colitis (UC) involving the left side of the colon
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female subjects are eligible if they are ≥ 18 years of age and ≤ 64 years
- •They have a documented history of idiopathic ulcerative colitis based on endoscopic and/or histologic findings involving the left side of the colon, with mild active disease or disease in remission.
- •Eligible subjects will have a documented history of ulcerative colitis, and a modified UCDAI with a sigmoidoscopy score of 1 point or less and Physician's rating of disease score of 1 point or less (mild or remission).
- •Laboratory data:
- •White blood cell count between 4,500 and 10,000 cells/mL
- •Platelet count: 150,000-450,000 cells/mL
- •Hemoglobin \> 10.0 g/dL
- •Total bilirubin \< 1.5 mg/dL
- •Aspartate aminotransferase \< 100 u/dL
- •Alanine aminotransferase \< 100 u/dL
Exclusion Criteria
- •Subjects will be excluded if:
- •They have documented history of proctitis or active proctitis confined to 15cm or less from the anal verge.
- •They demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.
- •They receive a Physician's rating of disease severity as part of the modified UCDAI of 2 or greater (moderate or severe disease) or an endoscopy score of 2 or greater.
- •They have shown evidence of high grade dysplasia on endoscopic examinations.
- •Their stool contains enteric pathogens or Clostridium difficile toxins.
- •They have a history of recurrent Clostridium difficile infection.
- •They have prior history of biologic therapy.
- •They have received systemic steroids or immunosuppressants within the previous 4 weeks.
- •Treatment in the last 2 weeks that included antibiotic, antifungal, antiparasitic medications, or rectally administered steroids (e.g. Cortenema®) and/or 5-ASA enema (e.g. Rowasa®).
Arms & Interventions
Comparator
Mesalamine enema
Intervention: mesalamine
Outcomes
Primary Outcomes
To determine the safety and tolerability of ALTH12 when given by intrarectal administration over 6 weeks to subjects with ulcerative colitis (UC) involving the left side of the colon
Time Frame: 6 weeks treatment