An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
This is a randomised, double-blind, placebo-controlled study to assess the safety and
tolerability of multiple ascending doses of BT051 in subjects with moderately to severely
active ulcerative colitis. Subjects will be randomised using a 3 active:1 placebo ratio to 3
ascending dose cohorts of 8 subjects and will be dosed daily for 28 days. The 3 initial dose
levels will be 200 mg, 800 mg and 3200 mg per day. Progression to the next cohort will be
based on the safety and tolerability of the previous cohort. An optional fourth cohort of up
to 20 additional subjects may be randomized 3 active:1 placebo at a dose no higher than 3200
mg at the discretion of the Sponsor.