Clinical Trial 42733

Boca Raton, FL 33487


Study Summary:

BBT-401-1S is an orally available small molecule drug, and you can take safely the oral capsule just once a day. BBT-401-1S is an investigational medication that inhibits the functions of the "Pellino-1" protein within the gastrointestinal tract. This protein is a part of the immune system within the human body that helps transmit immune response signals downstream. By neutralizing Pellino-1, BBT-401-1S works to disrupt and block the signals that can cause the body's immune system to attack cells within the colon and rectum and promote the inflammatory process implicated in Ulcerative Colitis. BBT-401-1S has demonstrated anti-UC success compared to the other therapies during the preclinical phase by displaying improved clinical symptoms and reduced cell inflammation during examination. This study has shown to be safe and well-tolerated when tested in healthy human volunteers during its Phase 1 trial study, with no traces of the drug absorbed or detected within the blood and the most common side effects being mild diarrhea and mild headaches. 


Qualified Participants Must:

• Be 18 years old and above
• Be diagnosed with UC at least 3 months prior to enrollment


Qualified Participants May Receive:

You will receive a daily oral dose of BBT-401-1S or placebo for 16 weeks. If you are assigned to Active Group, you will receive BBT-401-1S for the first 12 weeks and then placebo for the last 4 weeks. Or, if you are assigned to Placebo Group, you will receive placebo for the first 8 weeks and then BBT-401-1S for last 8 weeks. Throughout the treatment period, you will receive free physical examinations, blood and fecal lab tests, EKG's, and colonoscopies. 


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.