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Ulcerative Colitis (UC)Phase 1NCT07029971

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

A Phase 1 study testing BB-TL1A-VIAL-HLE in people with Ulcerative Colitis (UC), run by Vial Australia Pty Ltd at 2 sites in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Ulcerative Colitis (UC)
What is being tested?
BB-TL1A-VIAL-HLE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
2 sitesAustralia
Study dates
23 Jun 2025to 23 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Written informed consent to participate in the study and the ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures is provided.
  • Aged 18 to 55 years old (inclusive).
  • A weight of ≥50 kg and a body mass index between 18 and 32 kg/m2 (inclusive).
  • Considered healthy by the investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs.
  • Women of childbearing potential (WOCBP) may be considered if the participant is following the contraception guidance below in 5a. The participant will be questioned at each visit where there is a potential pregnancy. Similarly, male participants must follow the contraception guidance below in 5b.
  • Female participants meet this criterion if they are: i. Postmenopausal for at least 1 year before the first dose of study drug, including a serum FSH level of >40 mIU/mL to be reported to confirm menopause.
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  • OR ii. Surgically sterile (documented hysterectomy [by self-disclosure] or bilateral oophorectomy ≥90 days prior to enrollment).
  • OR iii. Abstinent from heterosexual intercourse as per usual lifestyle (self-reported).
  • OR iv. Using effective contraceptive methods for at least 6 weeks prior to enrollment and agree to continue effective contraceptive methods throughout study participation and up to 81 weeks (t1/2 x 5) after the last dose of the study drug.
  • Male participants meet this criterion if they agree to: i. Practice effective barrier contraception from the time of enrollment throughout study participation and up to 81 weeks (t1/2 x 5) after the last dose of the study drug.
  • OR ii. Be abstinent from heterosexual intercourse as per usual lifestyle (self-reported).
  • AND iii. Refrain from donating sperm during study participation and up to 81 weeks (t1/2 x 5) after the last dose of the study drug.
  • Non-smoker. If participant is a social smoker (up to 10 cigarettes per week), participant is willing to abstain during confinement.
  • Written informed consent to participate in the study and the ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures is provided.
  • Age ≥ 18 years.
  • A weight ≥ 50 kg and a body mass index (BMI) between 18 and 32 kg/m2 (inclusive).
  • Women of childbearing potential (WOCBP) and men must follow the contraception guidance as per the original protocol, ensuring no potential for pregnancy.
  • A confirmed diagnosis of UC for ≥ 3 months.
  • Moderate-to-severe UC, as defined by:
  • Aggregate UC severity score ≥ 4
  • Endoscopic severity score ≥ 2
  • Blood in stool score ≥ 1
  • Active disease beyond the rectum, with > 15 cm of active disease from the anal verge (confirmed by endoscopy).
  • Documented inadequate response, loss of response, or intolerance to ≥ 1 prior therapy from any of the following classes, confirmed by medical record OR investigator attestation OR patient-reported history (Investigator must confirm in the eCRF):
  • Systemic corticosteroids
  • Immunosuppressants
  • Anti-TNF agents
  • Anti-integrin inhibitors
  • Anti-IL-12/23 inhibitors
  • JAK inhibitors
  • S1PR modulators
  • If concomitantly taking 5-aminosalicylates, the participant must be on a stable dose for at least 4 weeks before baseline efficacy assessments.*
  • If concomitantly taking low-dose corticosteroids (≤ 20 mg/day), the participant must be on a stable dose for at least 2 weeks before baseline efficacy assessments.*
  • If concomitantly taking thiopurines, the participant must be on a stable dose for at least 8 weeks before baseline efficacy assessments.* *Baseline efficacy assessments include 7-Day Symptom Collection and Endoscopy.

Who cannot join

  • Allergy to the investigational drug or any of its components or clinically significant allergies (excluding mild seasonal allergies), in the opinion of the investigator.
  • Use of drugs with the same target and mechanism of action as the investigational product (TL1A targeting antibodies) within 30 days or 5 half-lives (whichever is longer) prior to screening.
  • History of tuberculosis (TB) or active, latent or inadequately treated TB infection. TB testing to be conducted at screening using QuantiFERON-TB Gold. Refer to a general practitioner for X-rays, etc. if required.
  • Clinically relevant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, drug hypersensitivity, or medication history making implementation of the protocol or interpretation of the study results difficult, or that would put the participant at risk by participating in the study in the opinion of the Investigator. History or fully resolved childhood asthma with no hospitalizations, that has had no recurrence as an adult are allowed.
  • Use of prescription medications, medical devices (other than hormonal contraception [e.g., oral contraceptive pills, long-acting implantable hormones, or injectable hormones], vaginal ring, or IUD) within 30 days prior to enrollment, or use of any over-the-counter (OTC) medications, herbal remedies, supplements, or vitamins within 30 days prior to enrollment and during the course of the study without prior approval of the Investigator and the independent Medical Monitor. Use of simple analgesics (e.g., paracetamol, a nonsteroidal anti-inflammatory drug [NSAID]) and antihistamines may be permitted at the discretion of the Investigator.
  • Evidence of malignancy or other clinically relevant abnormality in the opinion of the investigator at screening or within 5 years prior to Day 1, with the exception of squamous cell or basal cell carcinomas.
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  • Known or suspected autoimmune disorder.
  • Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCV Ab).
  • Administered a live attenuated vaccine within 28 days of enrollment (participants must also abstain from taking any live vaccines until at least 12 weeks after study completion).
  • A hospital admission or major surgery within 30 days prior to screening.
  • Participation in any other investigational drug trial within 30 days prior to screening or 5 half-lives, whichever is longer.
  • Confirmed or suspected COVID-19 infection within 14 days of any screening procedures.
  • Substance use disorder (SUD) and/or alcohol use disorder (AUD).
  • Other conditions that may affect compliance in the opinion of the investigator, or who is unable to participate in the study on his/her own.
  • The possible sites of injection (abdomen, front of thighs) have tattoos, scars, or significant dermatological disorders that prohibit the clear assessment of injection site reactions.
  • Blood donation ≤30 days prior to screening.
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN) at baseline.
  • Serum total bilirubin >2 times ULN at baseline.
  • Neutrophil count below 1,000 cells/µL at baseline.
  • Urea or serum creatinine >1.5 times ULN at baseline.
  • Employees or related personnel of the investigator, study site, or sponsor.
  • Diagnosis of Crohn's disease, indeterminate colitis, or UC limited to the rectum (< 15 cm from the anal verge).
  • Current evidence of fulminant colitis, toxic megacolon, or bowel perforation.
  • Active, serious infection requiring IV antibiotics within 4 weeks prior to enrollment.
  • History of cancer within 5 years, except for:
  • Cured non-melanoma skin cancer, OR
  • Localized cervical cancer treated definitively.
  • Hemaglobin < 8.0 g/dL at baseline.
  • Neutrophil count < 1.0 x 109/L at baseline.
  • Platelet count < 100 x 109/L at baseline.
  • Serum creatinine > 2x ULN at baseline.
  • ALT or AST > 3x ULN at baseline.
  • Total bilirubin > 2x ULN at baseline, unless the participant has a documented history of Gilbert's syndrome.
  • History of clinically significant drug or food allergy, including anaphylaxis or serious adverse reactions (excluding mild seasonal allergies).
  • History of untreated or inadequately treated latent or active tuberculosis (TB), or a positive QuantiFERON-TB Gold test at screening without prior appropriate therapy.
  • Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), or hepatitis C antibody (anti-HCV) at screening.
  • Receipt of a live attenuated vaccine within 28 days prior to the first dose of investigational product.
  • History of alcohol use disorder or substance use disorder (excluding nicotine or caffeine) within the past 12 months, as defined by DSM-5 criteria, that may interfere with study participation or pose additional risk.
  • Major surgery or hospitalization for any reason (excluding UC-related procedures) within 30 days prior to screening.
  • Use of investigational drugs or devices within 30 days of baseline efficacy assessments or 5 half-lives, whichever is longer.*
  • Use of biologics within 12 weeks of baseline efficacy assessments or 5 half-lives, whichever is longer.*
  • Use of rituximab within 1 year of baseline efficacy assessments.*
  • Use of parenteral corticosteroids within 4 weeks or rectal administration of corticosteroids within 2 weeks of baseline efficacy assessments.*
  • Rectal administration of 5-aminosalicylates within 2 weeks of baseline efficacy assessments.*
  • Use of tacrolimus, methotrexate, cyclosporine, mycophenolate mofetil, immunoadsorption columns, d-penicillamine, leflunomide, thalidomide, fish-oil preparations, probiotics, fecal transplantation, nonsteroidal anti-inflammatory agents (NSAIDs), and/or aspirin > 31 mg/day within 2 weeks of baseline efficacy assessments.*
  • Employees or related personnel of the investigator, study site, or sponsor. *Baseline efficacy assessments include 7-Day Symptom Collection and Endoscopy.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • Dymocks Building, WellShare Site

    Sydney, New South Wales, 2000

  • Arcadia Pittwater Private Hospital (Operated by Battery Bio)

    Warriewood, New South Wales, 2102

Other trials in Australia

About this study

Official title: 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

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.

Read more

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
Read the 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.

Being tested
BB-TL1A-VIAL-HLE
Keywords
Phase 1a/b, Ulcerative Colitis, BB-TL1A-VIAL-HLE, Battery Bio Australia Pty Ltd
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BB-TL1A-VIAL-HLEBiological

    Anti-TL1A monoclonal antibody

Study groups in NCT07029971
Study groupRoleWhat they receive
A1 Cohort: 15 mg, healthy volunteersExperimentalNot described
Receives: Biological: BB-TL1A-VIAL-HLE
A2 Cohort: 50 mg, healthy volunteersExperimentalNot described
Receives: Biological: BB-TL1A-VIAL-HLE
A3 Cohort: 150 mg, healthy volunteersExperimentalNot described
Receives: Biological: BB-TL1A-VIAL-HLE
A4 Cohort: 450 mg, healthy volunteersExperimentalNot described
Receives: Biological: BB-TL1A-VIAL-HLE
B1 Cohort: TBD mg, ulcerative colitisActive comparatorNot described
Receives: Biological: BB-TL1A-VIAL-HLE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting or intolerable treatment related adverse events

    Measured: From enrollment to the end of the follow up period at Day 355

  2. Incidence, severity and causal relationship of treatment emergent AEs (TEAEs) and withdrawals due to TEAEs

    Measured: From enrollment to the end of the follow up period at Day 355

  3. Incidence and magnitude of abnormal laboratory findings

    Measured: From enrollment to the end of the follow up period at Day 355

  4. Abnormal and clinically relevant changes in vital signs, blood pressure and electrocardiogram parameters

    Measured: From enrollment to the end of the follow up period at Day 355

  5. Percentage of participants who achieve endoscopic improvement at 12 weeks post-dose (Ph-1b)

    (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.

    Measured: From enrollment to end of induction period at 12 weeks

Secondary outcomes (14)

  1. Maximum observed plasma concentration (Cmax)

    Measured: From enrollment to end of follow up period at Day 355

  2. Time at which maximum plasma concentration is observed (Tmax)

    Measured: Enrollment to end of follow up period at Day 355

  3. Area under the plasma concentration-time profile from time zero to Day 15 (AUCDay15)

    Measured: Enrollment to end of follow up period on Day 355

  4. Area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (AUClast)

    Measured: Enrollment to end of follow up period at Day 355

  5. Area under the plasma concentration-time curve extrapolated to infinity (AUCinf)

    Measured: Enrollment to end of follow up period at Day 355

  6. Dose normalized maximum plasma concentration (Cmax[dn])

    Measured: Enrollment to end of follow up period at Day 355

  7. Dose normalized area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (AUClast[dn])

    Measured: Enrollment to end of follow up period at Day 355

  8. Half-life (t½)

    Measured: Enrollment to end of follow up period at Day 355

  9. Mean residence time (MRT)

    Measured: Enrollment to end of follow up period at Day 355

  10. Systemic clearance (CL)

    Measured: Enrollment to end of follow up period at Day 355

  11. Volume of distribution at steady state (Vss)

    Measured: Enrollment to end of follow up period at Day 355

  12. Percentage of participants who achieve clinical remission at 12 weeks post-dose (Ph-1b)

    (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.

    Measured: Baseline to 12 weeks post-dose

  13. Percentage of participants who achieve clinical response at 12 weeks post-dose (Ph-1b)

    (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.

    Measured: Baseline to 12 weeks post-dose

  14. Percentage of participants who achieve symptomatic remission at 12 weeks post-dose (Ph-1b)

    (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.

    Measured: Baseline to 12 weeks post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2025
  2. Study start23 Jun 2025
  3. Primary completion23 Dec 2025
  4. Study completion23 Dec 2025

Why it stopped: Study terminated based on interim analysis results indicating the primary pharmacokinetic endpoint was unlikely to be met.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Phase 1a: Single-ascending dose (SAD) cohorts Phase 1b: Single-arm, open-label
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07029971
Sponsor's protocol ID
BB-TL1A-1.0
Status last verified
Jan 2026
First submitted
12 Jun 2025
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BB-TL1A-VIAL-HLE in people with Ulcerative Colitis (UC), run by Vial Australia Pty Ltd at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated based on interim analysis results indicating the primary pharmacokinetic endpoint was unlikely to be met.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting or intolerable treatment related adverse events (time frame: From enrollment to the end of the follow up period at Day 355). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07029971.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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