NCT07029971

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

A Phase 1a/b Clinical Trial To Determine the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Efficacy of BB-TL1A-VIAL-HLE in Healthy Adult Volunteers and in Patients With Moderate-To-Severe Ulcerative Colitis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Vial Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

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.

Conditions

• Ulcerative Colitis (UC)

Interventions

Type	Name	Description
BIOLOGICAL	BB-TL1A-VIAL-HLE	Anti-TL1A monoclonal antibody

Timeline

• Start date: 2025-06-23
• Primary completion: 2025-12-23
• Completion: 2025-12-23
• First posted: 2025-06-19
• Last updated: 2026-01-22

Locations

2 sites across 1 country: Australia