Overview
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.
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.
Eligibility
Inclusion Criteria:
- Male or female adults aged ≥ 19 to ≤ 75 years
[Parts 1 and 2 only]
- Diagnosis of CSU at least 6 months prior to screening
- Diagnosis of CSU inadequately controlled on 2nd-generation H1 antihistamines at the time of randomization
[Part 2 only]
- Experience of inadequately uncontrolled CSU despite use of omalizumab
[Part 3 only]
- Diagnosis of chronic inducible urticaria (cold urticaria) at least 3 months prior to screening
- Diagnosis of chronic inducible urticaria (cold urticaria) inadequately controlled on 2nd-generation H1 antihistamines at the time of randomization
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's
potential participation in a clinical trial.