None listed
Conditions
Brief summary
Vial Australia Pty Ltd is conducting a first-in-human study of VIAL-IL13xTSLP, an experimental bispecific antibody that targets two inflammatory proteins (IL-13 and TSLP) involved in asthma. The study will evaluate the safety, tolerability, and biological effects of the drug in healthy volunteers.
Interventions
Required 1a Cohorts: VIAL-IL13xTSLP administered as a single open-label, non-randomised intravenous infusion to healthy volunteers at five ascending dose levels (15, 50, 150, 400, and 800 mg); no placebo is administered.
Optional 1a Cohorts: VIAL-IL13xTSLP administered as a single open-label, non-randomised intravenous infusion to healthy volunteers at one additional dose level (between 800 and 1600 mg); and/or as a single open-label, non-randomised subcutaneous injection at up to two additiona
Required 1a Cohorts: VIAL-IL13xTSLP administered as a single open-label, non-randomised intravenous infusion to healthy volunteers at five ascending dose levels (15, 50, 150, 400, and 800 mg); no placebo is administered. Optional 1a Cohorts: VIAL-IL13xTSLP administered as a single open-label, non-randomised intravenous infusion to healthy volunteers at one additional dose level (between 800 and 1600 mg); and/or as a single open-label, non-randomised subcutaneous injection at up to two additional dose levels (up to 1600 mg); no placebo is administered. Initiation of optional cohorts is contingent upon Safety Review Committee approval following review of safety and tolerability data. Adherence: Adherence is assured by on-site administration under direct medical supervision, with all participants followed for safety, pharmacokinetic, and pharmacodynamic assessments through Day 251 post-dose.
Sponsors
Vial Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
All Participants: - Body Mass Index (BMI) 18–32 kg/m² - Considered healthy per investigator assessment - Adequate contraception (females must use effective contraception, be postmenopausal, surgically sterile, or abstinent; males must use barrier contraception or be abstinent and refrain from sperm donation)
Exclusion criteria
- Clinically significant medical history or concomitant medications - Active/latent TB - Malignancy within 5 years - Autoimmune disorders - HIV/HBV/HCV positivity - Elevated liver/renal markers - Eosinophilic disease - Substance/alcohol use disorder - Prior IL-13/TSLP biologics - Live vaccine within 28 days.
Outcome results
None listed