Efficacy and Safety of Oral BT-11 in Ulcerative Colitis

Key Inclusion Criteria: 1. . Male and female subjects aged 18 to 75 years, inclusive. 2. . Diagnosis of UC for at least 3 months prior to screening. 3. . UC, as defined by a total Mayo Score of 4 to 10 inclusive at baseline with a MES 2 (confirmed by central reader). 4. . Able to participate fully in all aspects of this clinical trial. 5. . Written informed consent must be obtained and documented. Key Exclusion Criteria: 1. . A diagnosis of CD, indeterminate colitis, or presence or history of the fistula with CD. 2. . Modified Truelove and Witts criteria (2: 6 bloody stools per day and one or more of the following: pulse \> 90 bpm, temperature \> 37.8°C, hemoglobin \< 10.5 g/dl, or hs-CRP \> 30 mg/I). 3. . Disease activity limited to distal 15 cm (proctitis). 4. . Treatment with an immunosuppressant (azathioprine, 6- mercaptopurine \[6-MP\]) within 25 days prior to randomization. 5. . Unable to attend study visits or comply with procedures. 6. . Concurrent participation in any other interventional study. 7. . Prior enrollment in the current study and had received study treatment.