Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07029971




Registration number
NCT07029971
Ethics application status
Date submitted
12/06/2025
Date registered
19/06/2025
Date last updated
19/06/2025

Titles & IDs
Public title
A First-in-Human Study of BB-TL1A-VIAL-HLE in Healthy Adults and People With Ulcerative Colitis
Scientific 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
Secondary ID [1] 0 0
BB-TL1A-1.0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis (UC) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - BB-TL1A-VIAL-HLE

Experimental: A1 Cohort: 15 mg, healthy volunteers -

Experimental: A2 Cohort: 50 mg, healthy volunteers -

Experimental: A3 Cohort: 150 mg, healthy volunteers -

Experimental: A4 Cohort: 450 mg, healthy volunteers -

Active comparator: B1 Cohort: TBD mg, ulcerative colitis -


Treatment: Other: BB-TL1A-VIAL-HLE
Anti-TL1A monoclonal antibody
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose limiting or intolerable treatment related adverse events
Timepoint [1] 0 0
From enrollment to the end of the follow up period at Day 355
Primary outcome [2] 0 0
Incidence, severity and causal relationship of treatment emergent AEs (TEAEs) and withdrawals due to TEAEs
Timepoint [2] 0 0
From enrollment to the end of the follow up period at Day 355
Primary outcome [3] 0 0
Incidence and magnitude of abnormal laboratory findings
Timepoint [3] 0 0
From enrollment to the end of the follow up period at Day 355
Primary outcome [4] 0 0
Abnormal and clinically relevant changes in vital signs, blood pressure and electrocardiogram parameters
Timepoint [4] 0 0
From enrollment to the end of the follow up period at Day 355
Primary outcome [5] 0 0
Percentage of participants who achieve clinical response at 8 weeks post-dose (Ph-1b)
Timepoint [5] 0 0
From enrollment to end of induction period at 8 weeks
Secondary outcome [1] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [1] 0 0
From enrollment to end of follow up period at Day 355
Secondary outcome [2] 0 0
Time at which maximum plasma concentration is observed (Tmax)
Timepoint [2] 0 0
Enrollment to end of follow up period at Day 355
Secondary outcome [3] 0 0
Area under the plasma concentration-time profile from time zero to Day 15 (AUCDay15)
Timepoint [3] 0 0
Enrollment to end of follow up period on Day 355
Secondary outcome [4] 0 0
Area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (AUClast)
Timepoint [4] 0 0
Enrollment to end of follow up period at Day 355
Secondary outcome [5] 0 0
Area under the plasma concentration-time curve extrapolated to infinity (AUCinf)
Timepoint [5] 0 0
Enrollment to end of follow up period at Day 355
Secondary outcome [6] 0 0
Dose normalized maximum plasma concentration (Cmax[dn])
Timepoint [6] 0 0
Enrollment to end of follow up period at Day 355
Secondary outcome [7] 0 0
Dose normalized area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (AUClast[dn])
Timepoint [7] 0 0
Enrollment to end of follow up period at Day 355
Secondary outcome [8] 0 0
Half-life (t½)
Timepoint [8] 0 0
Enrollment to end of follow up period at Day 355
Secondary outcome [9] 0 0
Mean residence time (MRT)
Timepoint [9] 0 0
Enrollment to end of follow up period at Day 355
Secondary outcome [10] 0 0
Systemic clearance (CL)
Timepoint [10] 0 0
Enrollment to end of follow up period at Day 355
Secondary outcome [11] 0 0
Volume of distribution at steady state (Vss)
Timepoint [11] 0 0
Enrollment to end of follow up period at Day 355

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
23/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Dymocks Building, WellShare Site - Sydney
Recruitment hospital [2] 0 0
Arcadia Pittwater Private Hospital (Operated by Battery Bio) - Warriewood
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
2102 - Warriewood

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Battery Bio Australia Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
General Manager, Therapeutics Operations
Address 0 0
Country 0 0
Phone 0 0
647-924-0691
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07029971