A Single and Repeat Dosing Study of the Safety, Drug Exposure, and Clinical Activity of R-3750 in Patients With Mild to Moderate Ulcerative Colitis
Rise Therapeutics LLC
Summary
The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate ulcerative colitis. Patients will take an oral dosage of probiotic (R-3750) and provide patient-reported and physician scored measures of their colitis. Blood and fecal evaluations of inflammation and assessment of probiotic (R-3750) on fecal levels will also be measured.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA: * 18-65 years of age * Ability to provide written informed consent * Confirmed diagnosed with UC by colonoscopy and histology and suffering from mild to moderate UC as defined by MMDAI with score of 3-9 * On a stable dose of aminosalicylate (i.e. no change in medication within 4 weeks of study enrollment) and not planning to initiate new medication other than the study drug * For women of childbearing potential or men with a partner of childbearing potential, agree to use birth control methods (including hormonal contraceptives, intrauterine device (IUD) or hormone releasi…
Interventions
- DrugR-3750
Probiotic
Locations (4)
- Amicis Research CenterValencia, California
- AP Medical Research LLCMiami, Florida
- Edward Jenner Research Group, LLCPlantation, Florida
- Mayo ClinicRochester, Minnesota