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

This is a Phase 1a/b integrated clinical investigation. Phase 1a is an open-label, single-ascending dose (SAD) study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of BB-TL1A-VIAL-HLE in healthy volunteers. Phase 1b is a single-arm, open-label study evaluating the safety, PK, PD, immunogenicity, and efficacy of a single dose of BB-TL1A-VIAL-HLE in patients with moderate-to-severe ulcerative colitis.