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

Launched by BATTERY BIO AUSTRALIA PTY LTD · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BB-TL1A-VIAL-HLE to see if it is safe for healthy adults and if it can help adults with moderate-to-severe ulcerative colitis, a condition that causes inflammation and sores in the large intestine. The main goals are to find out whether this treatment is safe and if it works better than existing options for people with ulcerative colitis.

If you join the study, you may be either a healthy adult between 18 and 55 years old or someone with moderate-to-severe ulcerative colitis who meets certain health requirements. Participants will visit the research site several times over about a year, where they will have blood and urine tests, physical exams, and receive one injection of the study drug. The study team will closely monitor your health throughout the trial to ensure safety. It’s important to know that certain health conditions, medications, or recent vaccinations might affect eligibility, and women and men of childbearing age will need to follow specific birth control guidelines during and after the study. This trial is currently recruiting participants who are interested in helping researchers learn more about this new potential treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria (Phase 1a):
• • 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:
• • 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
• • Surgically sterile (documented hysterectomy \[by self-disclosure\] or bilateral oophorectomy ≥90 days prior to enrollment).
• • OR
• • Abstinent from heterosexual intercourse as per usual lifestyle (self-reported).
• • OR
• • 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:
• • 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
• • Be abstinent from heterosexual intercourse as per usual lifestyle (self-reported).
• • AND
• • 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.
• Exclusion Criteria (Phase 1a):
• • 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.
• • 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.
• Inclusion Criteria (Phase 1b):
• • Participant meets all inclusion criteria defined for Phase 1a.
• • Moderately-to-severely active ulcerative colitis at screening/baseline (defined as a modified Mayo score \[mMS\] of 5-9 and an endoscopic subscore of at least 2).
• • If the participant is concomitantly taking 5-aminosalicylates, the participant must be on a stable dose for at least 4 weeks before enrollment.\*
• • If the participant is concomitantly taking low-dose oral/rectal corticosteroids (≤20mg per day), the participant must be on a stable dose for at least 2 weeks before enrollment.\*
• • If the participant is concomitantly taking thiopurines, the participant must be on a stable dose for at least 8 weeks before enrollment.\*
• Exclusion Criteria (Phase 1b):
• • Participant does not meet any exclusion criteria defined in Phase 1a (except for Phase 1a exclusion criterion #5 and criterion #7 in the case of ulcerative colitis).
• • Use of Janus kinase (JAK) inhibitors within 7 days of enrollment or 5 half-lives, whichever is longer.\*
• • Use of biologics (antibody therapies) within 12 weeks of enrollment or 5 half-lives, whichever is longer.\*
• • Use of any injected corticosteroids OR oral/rectal corticosteroids \>20mg per day within 2 weeks of enrollment.\*
• • Use of methotrexate or calcineurin inhibitors within 30 days of enrollment or 5 half-lives, whichever is longer.\*
• • \*All applicable washout/dose stabilization periods must be completed before the daily symptom collection (stool frequency \& rectal bleeding) and endoscopy (flexible sigmoidoscopy) are performed during the screening period.