NCT07281703

Evaluation of the Safety, Tolerability and Pharmacokinetics of HY8931 in Healthy Adult Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HY8931 Following Single Intravenous and Multiple Subcutaneous Doses in Healthy Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Newsoara Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	HY8931	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.
OTHER	Placebo Control	A vial with 1ml injection solution contain same ingredient except HY8931 compared with HY8931 solution.

Timeline

• Start date: 2026-01-14
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2025-12-15
• Last updated: 2026-03-11

Locations

1 site across 1 country: Australia