Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Comparator Mesalamine enema |
Drug: mesalamine
4.0g mesalamine rectal suspension, rectally administered enema, 60ml volume, 4.0g mesalamine, once daily
Other Names:
|
| Experimental: ALTH12-1:4 ALTH12-1:4 experimental treatment dose |
Drug: ALTH12-1:4
ALTH12-1:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 1.0g N-acetylcysteine
Other Names:
|
| Experimental: ALTH12-2:4 ALTH12-2:4 experimental treatment dose |
Drug: ALTH12-2:4
ALTH12-2:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 2.0g N-acetylcysteine
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 [6 weeks treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female subjects are eligible if they are ≥ 18 years of age and ≤ 64 years
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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.
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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).
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Laboratory data:
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White blood cell count between 4,500 and 10,000 cells/mL
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Platelet count: 150,000-450,000 cells/mL
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Hemoglobin > 10.0 g/dL
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Total bilirubin < 1.5 mg/dL
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Aspartate aminotransferase < 100 u/dL
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Alanine aminotransferase < 100 u/dL
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Alkaline phosphatase < 250 u/dL
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Blood urine nitrogen < 40 mg/dL
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Creatinine < 1.5 mg/dL
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Amylase < 150 U/L
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Satisfied one of the following:
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Female subjects of childbearing potential must have a negative serum pregnancy test at screening; surgically sterile, post-menopausal, abstinent, or patient or partner agree to use a medically appropriate form of birth control from screening to until 1 month after the last dose of study medication.
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Male subjects must be surgically sterile, abstinent, or patient or partner compliant with a contraceptive regimen from screening to until 1 month after the last dose of study medication.
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They are able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
Exclusion Criteria:
Subjects will be excluded if:
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They have documented history of proctitis or active proctitis confined to 15cm or less from the anal verge.
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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.
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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.
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They have shown evidence of high grade dysplasia on endoscopic examinations.
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Their stool contains enteric pathogens or Clostridium difficile toxins.
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They have a history of recurrent Clostridium difficile infection.
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They have prior history of biologic therapy.
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They have received systemic steroids or immunosuppressants within the previous 4 weeks.
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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®).
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They have a history of cancer (defined as malignancy within 5 years except for squamous cell or basal cell cancers of the skin), asthma, or bronchospasm.
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Positive pregnancy test or lactating subjects.
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There is evidence of chemical abuse.
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They have a known allergy to N-acetylcysteine or Mesalamine.
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They have a history of failure to retain enemas.
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Other clinically significant diseases that could interfere with the protocol compliance appear. These would include clinically important hematological, renal, hepatic, metabolic, psychiatric, central nervous system (CNS), pulmonary or cardiovascular disease.
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Any condition which the study physician judges to preclude safe participation in the study or to confound the evaluation of the study outcome.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma | United States | 73104 |
Sponsors and Collaborators
- Altheus Therapeutics, Inc.
Investigators
- Principal Investigator: Philip B Miner, M.D., Oklahoma Foundation for Digestive Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALTH12-003