The goal of this clinical trial is to learn the safety, tolerability and pharmacokinetics of single and multiple doses of HY8931 in healthy adult participants. The main questions it aims to answer are: * How is the safety and tolerability following administration of single and multiple doses of HY8931 in healthy adult participants? * What is the PK character of HY8931 following administration of single and multiple doses of HY8931 in healthy adult participants? Researchers will compare HY8931 to a placebo (a look-alike substance that contains no drug) to see if HY8931 is safe and well tolerated. Participants will take HY8931 or a placebo once or twice in single dose group or multiple dose group. And will be follow-up until Day 90.
The rationale of the study is by simultaneously targeting TL1A and IL-23p19, HY8931 as an investigational bispecific antibody, presents a novel and promising therapeutic strategy. It has the potential to disrupt multiple pathogenic pathways in IBD, effectively breaking the vicious cycle of inflammation. Pre-clinical studies have demonstrated that the dual inhibition of these cytokines can effectively reduce eosinophilic inflammation, airway hyperresponsiveness, and tissue remodeling in animal models. This approach holds the potential to not only alleviate acute symptoms but also modify the disease course, offering a more comprehensive and effective treatment strategy for patients suffering from these debilitating respiratory conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
60
HY8931 is an injection solution with 125mg/ml per vial. SAD part for intravenous dosing in 6 cohorts, including 10mg, 30mg, 60mg, 120mg, 240mg and 360mg and for subcutaneous dosing in 1 cohort of 120mg with only one administration on Day 1 of each cohort. MAD part for subcutaneous dosing in 3 cohorts, including 120mg, 240mg and 360mg with two administrations on Day 1 and Day 30 of each cohort.
A vial with 1ml injection solution contain same ingredient except HY8931 compared with HY8931 solution.
Q-Pharm Pty Ltd.
Brisbane, Australia
RECRUITINGNumber of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: From signing informed consent form to the end of study at Day 90.
Peak Plasma Concentration (Cmax)
Time frame: From Day1 predose to Day 90.
Area under the plasma concentration versus time curve (AUC)
Time frame: From Day1 predose to Day 90.
Time to maximum concentration (Tmax)
Time frame: From Day1 predose to Day 90.
Plasma half-life time (T1/2)
Time frame: From Day1 predose to Day 90.
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