Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
Study NCT ID:
NCT07281703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety, Tolerability and Pharmacokinetics of HY8931 in Healthy Adult Participants
Sponsor:
Newsoara Biopharma Co., Ltd.
Organization:
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: