Clinical Trial

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

Terminated Phase 1
View on ClinicalTrials.gov →
Why the trial stopped
Study terminated based on interim analysis results indicating the primary pharmacokinetic endpoint was unlikely to be met.
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
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-06-12; most recent amendment 2026-01-20.
Status change: Recruiting → Terminated 2026-01-20
Trial Details
NCT Number NCT07029971
Lead Sponsor Vial Australia Pty Ltd
Conditions Ulcerative Colitis (UC)
Enrollment 16 participants
Start Date 2025-06-23
Primary Completion 2025-12-23 (estimated)
Study Completion 2025-12-23 (estimated)
Updated on ClinicalTrials.gov 2026-01-22