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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• 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.

• 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.

Locations
Other Locations
Australia
Dymocks Building, WellShare Site
RECRUITING
Sydney
Arcadia Pittwater Private Hospital (Operated by Battery Bio)
RECRUITING
Warriewood
Contact Information
Primary
Chief Operations Officer
joshua.pascoe@vial.com
647-924-0691
Backup
Associate, Clinical Development
collin@vial.com
385-236-6228
Time Frame
Start Date: 2025-06-23
Estimated Completion Date: 2026-12
Participants
Target number of participants: 34
Treatments
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
Sponsors
Leads: Battery Bio Australia Pty Ltd

This content was sourced from clinicaltrials.gov