Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05960708
Status:
COMPLETED
Last Update Posted:
2024-04-22
First Post:
2023-07-13
Brief Title:
A Single Dose Phase 1 Study of YH35324 in Patients With Various Allergic Diseases
Sponsor:
Yuhan Corporation
Organization:
Yuhan Corporation
Study Overview
Official Title:
A Randomized Double-Blind PlaceboActive Controlled Single Dose Phase 1 Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of YH35324 in Patients With Various Allergic Diseases
Status:
COMPLETED
Status Verified Date:
2024-09
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:
This study aims to evaluate the safety tolerability pharmacokinetics PK and pharmacodynamics PD following a single subcutaneous injection of YH35324 in subjects with various allergic diseases
Detailed Description:
This drugYH35324 is currently under development as a novel therapeutic agent for various IgE-mediated allergic diseases Since YH35324 exhibits high binding affinity to human IgE it prevents serum IgE from binding to receptors on mast cells and basophils thereby inhibiting histamine release via degranulation following allergen exposures In addition YH35324 suppresses autoantibody-dependent effector cell activation by blocking anti-FcεRIα autoantibodies This study aims to evaluate the safety tolerability pharmacokinetics PK and pharmacodynamics PD following a single subcutaneous injection of YH35324 in subjects with various allergic diseases
Study Oversight
Has Oversight DMC:
None
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?:
None