NCT05960708

A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases

A Randomized, Double-Blind, Placebo/Active 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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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 drug(YH35324) 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.

Conditions

• Allergic Disease
• Chronic Spontaneous Urticaria
• Chronic Inducible Urticaria
• Cold Urticaria

Interventions

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

Timeline

• Start date: 2023-08-23
• Primary completion: 2024-09-13
• Completion: 2024-09-13
• First posted: 2023-07-27
• Last updated: 2024-11-22

Locations

9 sites across 1 country: South Korea