NCT05061524

A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases

A First-in-Human, Randomized, Double-Blind, Placebo/Active Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following Subcutaneous Injections of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, PK, and PD following subcutaneous injections of YH35324 in atopic healthy subjects or adult subjects with mild allergic diseases. Eligible subjects will be randomized to the YH35324 group, the placebo group, or the omalizumab group.

Detailed description

YH35324 is a drug under development as a novel therapeutic agent for various IgE-mediated allergic diseases. Since YH35324 has a high binding affinity to human IgE, it prevents serum IgE from binding to receptors on mast cells and basophil, thereby inhibiting histamine release caused by degranulation when exposed to allergens Based on its non-clinical study results, this study aims to evaluate the safety, tolerability, PK, and PD following subcutaneous injections of YH35324 in atopic healthy subjects or subjects with mild allergic diseases.

Conditions

• Atopic Healthy Subjects
• Adult Subjects with Mild Allergic Diseases

Interventions

Type	Name	Description
DRUG	YH35324	Subcutaneous injection of YH35324
DRUG	Placebo	Subcutaneous injection of None of active ingredient
DRUG	Omalizumab	Subcutaneous injection of Omalizumab

Timeline

• Start date: 2021-09-26
• Primary completion: 2023-01-25
• Completion: 2023-01-25
• First posted: 2021-09-29
• Last updated: 2024-12-03

Locations

4 sites across 1 country: South Korea