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

Phase 1

Recruiting

• Conditions: Ulcerative Colitis (UC)
• Interventions: Biological: BB-TL1A-VIAL-HLE

• Registration Number: NCT07029971
• Lead Sponsor: Battery Bio Australia Pty Ltd

Brief 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.

Study Timeline

• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-12
• Study First Posted: 2025-06-19
• Study Start: 2025-06-23
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-02
• Last Update Posted: 2025-09-08
• Primary Completion: 2026-03
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
A1 Cohort: 15 mg, healthy volunteers	BB-TL1A-VIAL-HLE	-
A2 Cohort: 50 mg, healthy volunteers	BB-TL1A-VIAL-HLE	-
A3 Cohort: 150 mg, healthy volunteers	BB-TL1A-VIAL-HLE	-
A4 Cohort: 450 mg, healthy volunteers	BB-TL1A-VIAL-HLE	-
B1 Cohort: TBD mg, ulcerative colitis	BB-TL1A-VIAL-HLE	-

Primary Outcome Measures

Name	Time	Method
Incidence of dose limiting or intolerable treatment related adverse events	From enrollment to the end of the follow up period at Day 355
Incidence, severity and causal relationship of treatment emergent AEs (TEAEs) and withdrawals due to TEAEs	From enrollment to the end of the follow up period at Day 355
Incidence and magnitude of abnormal laboratory findings	From enrollment to the end of the follow up period at Day 355
Abnormal and clinically relevant changes in vital signs, blood pressure and electrocardiogram parameters	From enrollment to the end of the follow up period at Day 355
Percentage of participants who achieve endoscopic improvement at 12 weeks post-dose (Ph-1b)	From enrollment to end of induction period at 12 weeks	(defined as an endoscopic severity score\* of ≤1 with no friability); \*The endoscopic severity score range is 0-3 with a higher score indicating higher severity.

Secondary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	From enrollment to end of follow up period at Day 355
Area under the plasma concentration-time curve extrapolated to infinity (AUCinf)	Enrollment to end of follow up period at Day 355
Dose normalized area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (AUClast[dn])	Enrollment to end of follow up period at Day 355
Volume of distribution at steady state (Vss)	Enrollment to end of follow up period at Day 355
Percentage of participants who achieve symptomatic remission at 12 weeks post-dose (Ph-1b)	Baseline to 12 weeks post-dose	(defined as a bowel movement frequency score\* of 0 and blood in stool score\*\* of 0); \*The bowel movement frequency score range is 0-3 with a higher score indicating higher severity.; \*\*The blood in stool score range is 0-3 with a higher score indicating higher severity.
Time at which maximum plasma concentration is observed (Tmax)	Enrollment to end of follow up period at Day 355
Area under the plasma concentration-time profile from time zero to Day 15 (AUCDay15)	Enrollment to end of follow up period on Day 355
Dose normalized maximum plasma concentration (Cmax[dn])	Enrollment to end of follow up period at Day 355
Area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (AUClast)	Enrollment to end of follow up period at Day 355
Half-life (t½)	Enrollment to end of follow up period at Day 355
Systemic clearance (CL)	Enrollment to end of follow up period at Day 355
Mean residence time (MRT)	Enrollment to end of follow up period at Day 355
Percentage of participants who achieve clinical remission at 12 weeks post-dose (Ph-1b)	Baseline to 12 weeks post-dose	(defined as an endoscopic severity score\* of ≤ 1, ≥ 1-point decrease from baseline to achieve a bowel movement frequency score\*\* of ≤ 1, and blood in stool score\*\*\* of 0); \*The endoscopic severity score range is 0-3 with a higher score indicating higher severity.; \*\*The bowel movement frequency score range is 0-3 with a higher score indicating higher severity.; \*\*\*The blood in stool score range is 0-3 with a higher score indicating higher severity.
Percentage of participants who achieve clinical response at 12 weeks post-dose (Ph-1b)	Baseline to 12 weeks post-dose	(defined as a decrease from baseline in the aggregate ulcerative colitis severity score\* of ≥ 2 points and ≥30% reduction from baseline, and a decrease in blood in stool score\*\* of ≥ 1 or an absolute blood in stool score of ≤ 1); \*The aggregate ulcerative colitis severity score range is 0-9 comprised of three subscores (blood in stool score, bowel movement frequency score, and endoscopic severity score) with a higher score indicating higher severity of ulcerative colitis.; \*\*The blood in stool score range is 0-3 with a higher score indicating higher severity.

Trial Locations

Locations (2)

Dymocks Building, WellShare Site; 🇦🇺 Sydney, New South Wales, Australia

Arcadia Pittwater Private Hospital (Operated by Battery Bio); 🇦🇺 Warriewood, New South Wales, Australia