Phase 1B randomized, double-blind, placebo-controlled, two-cohort clinical trial of ABI-M201 in adult subjects with mildly-to-moderately active Ulcerative Colitis(UC) and ongoing treatment with mesalamine.
This multi-center randomized, double-blind, placebo-controlled study will evaluate the safety of ABI-M201 and its effects on disease activity measures in men and women with mildly-to-moderately active UC and ongoing treatment with mesalamine. The study will consist of 2 sequential, non-overlapping participant cohorts, separated by intervening interim analysis (IA). Both cohorts will involve 8-weeks of study drug treatment. Interim data from the initial treatment cohort (Cohort A) will inform decision to advance to the subsequent second cohort (Cohort B) and its dose selection. 20 subjects will be randomized to cohort A (1:1 allocation) and receive treatment with 1 capsule per day of ABI-M201 versus Placebo. 24 subjects will be randomized to cohort B (3:1 allocation) and receive treatment with up to 5 capsules one time a day of ABI-M201 versus Placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
(Investigator site)
Oakland, California, United States
(Investigator Site)
San Carlos, California, United States
(Investigator Site)
Decatur, Georgia, United States
Incidence of Treatment-Emergent Adverse Events
\[Safety\]
Time frame: 8-weeks
Incidence of Treatment-Emergent Laboratory Abnormalities
\[Safety\]
Time frame: 8-weeks
Clinical Remission
\[UC Disease Activity\]
Time frame: 8-weeks
Endoscopic Improvement
\[UC Disease Activity\]
Time frame: 8-weeks
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(Investigator Site)
Shreveport, Louisiana, United States
(Investigator Site)
Chesterfield, Michigan, United States
(Investigator Site)
Ypsilanti, Michigan, United States
(Investigator Site)
Rochester, Minnesota, United States
(Investigator Site)
Jackson, Tennessee, United States
(Investigator Site)
Bellevue, Washington, United States
(Investigator Site)
Milwaukee, Wisconsin, United States
...and 1 more locations