This is a Phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with moderately to severely active UC. Randomization will be stratified by Mayo score.~Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period. The total duration of the study will be 20 weeks, excluding the screening period.~The primary objective is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active UC.~The secondary objectives are to evaluate the effect of PRV-300 for 12 weeks in subjects with active UC on:~Pharmacodynamics: Changes in gene scores in colonic biopsies over the course of treatment.~Pharmacokinetics: Peak (Cmax) and trough (Cmin) serum concentrations of PRV-300 in subjects with active UC.~Immunogenicity: Immunogenicity of PRV-300 in subjects with active UC~Endoscopic: Trends in endoscopic disease activity in subjects with active UC.
The purpose of this study is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active ulcerative colitis.~Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period.