A First-in-Human Study of BB-TL1A-VIAL-HLE in Healthy Adults and People With Ulcerative Colitis

Summary

The goal of this clinical trial is to learn if BB-TL1A-VIAL-HLE is safe in healthy adults and is safe and effective in treating adults with moderate-to-severe ulcerative colitis. The main questions it aims to answer are: Is the intervention safe in healthy adults and in adults with moderate-to-severe ulcerative colitis? Is the intervention effective in treating adults with moderate-to-severe ulcerative colitis? Researchers will compare the Phase 1b arm to a historical treatment arm to estimate the drug's effect size and see if the study drug is at least as effective as a relevant benchmark. Participants will: * Attend the clinical research site several times over the course of \~1 year * Have blood and urine samples taken * Undergo physical examinations * Receive one injection of the study drug

Timeline

Start

2025-06-23

Primary completion

2025-12-23

Completion

2025-12-23

Outcome

Outcome not reported

Stopped: “Study terminated based on interim analysis results indicating the primary pharmacokinetic endpoint was unlikely to be met.”

Drugs

Indications