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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.
Full 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.
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Inclusion criteria
[Parts 1 and 2 only]
[Part 2 only]
[Part 3 only]
Exclusion criteria
[Parts 1 and 2 only]
[Part 3 only]
The above information is not intended to contain all considerations relevant to a patient potential participation in a clinical trial.
Primary purpose
Allocation
Interventional model
Masking
30 participants in 3 patient groups, including a placebo group
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Central trial contact
Eunji Song; JungWook Ahn
Data sourced from clinicaltrials.gov
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