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

NCT07029971 | Terminated Phase 1 DMC

• 1 other identifier: BB-TL1A-1.0
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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

Conditions

Ulcerative Colitis (UC)

Keywords

Phase 1a/b; Ulcerative Colitis; BB-TL1A-VIAL-HLE; Battery Bio Australia Pty Ltd

Outcome Measures

Primary Outcomes (5)

• 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)

  (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.

  From enrollment to end of induction period at 12 weeks

Secondary Outcomes (14)

• Maximum observed plasma concentration (Cmax)

  From enrollment to end of follow up period at Day 355

• 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

• 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

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

  Enrollment to end of follow up period at Day 355

Study Arms (5)

A1 Cohort: 15 mg, healthy volunteers

EXPERIMENTAL

Biological: BB-TL1A-VIAL-HLE

A2 Cohort: 50 mg, healthy volunteers

EXPERIMENTAL

Biological: BB-TL1A-VIAL-HLE

A3 Cohort: 150 mg, healthy volunteers

EXPERIMENTAL

Biological: BB-TL1A-VIAL-HLE

A4 Cohort: 450 mg, healthy volunteers

EXPERIMENTAL

Biological: BB-TL1A-VIAL-HLE

B1 Cohort: TBD mg, ulcerative colitis

ACTIVE COMPARATOR

Biological: BB-TL1A-VIAL-HLE

Interventions

BB-TL1A-VIAL-HLE BIOLOGICAL

Anti-TL1A monoclonal antibody

A1 Cohort: 15 mg, healthy volunteers; A2 Cohort: 50 mg, healthy volunteers; A3 Cohort: 150 mg, healthy volunteers; A4 Cohort: 450 mg, healthy volunteers; B1 Cohort: TBD mg, ulcerative colitis

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• a. 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.
• 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.
• b. 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Vial Australia Pty Ltd: lead

Study Sites (2)

Dymocks Building, WellShare Site

Sydney, New South Wales, 2000, Australia

Location

Arcadia Pittwater Private Hospital (Operated by Battery Bio)

Warriewood, New South Wales, 2102, Australia

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1a: Single-ascending dose (SAD) cohorts Phase 1b: Single-arm, open-label

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 19, 2025
• Study Start: June 23, 2025
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

AU (2)