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

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.

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.

Inclusion Criteria:

• Male or female adults aged ≥ 19 to ≤ 75 years

[Parts 1 and 2 only]

• Diagnosis of CSU

[Part 2 only]

• Experience of inadequately uncontrolled CSU despite use of omalizumab

[Part 3 only]

• Diagnosis of chronic inducible urticaria (cold urticaria)

Exclusion Criteria:

• History of malignancy within 5 years from screening
• Aspartate transaminase (AST) or alanine transaminase (ALT) level > 2 X the upper limit of normal

[Parts 1 and 2 only]

• Chronic urticaria with clear etiology other than CSU

[Part 3 only]

• Chronic urticaria other than studied chronic inducible urticaria (cold urticaria)

The above information is not intended to contain all considerations relevant to a patient potential participation in a clinical trial.