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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Allergic Disease, Chronic Spontaneous Urticaria, Chronic Inducible Urticaria, Cold Urticaria

Intervention / Treatment
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* Drug: YH35324
* Drug: Omalizumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YH35324<br>[Part 1] A total of 18 subjects will be randomized in a 1:1:1 ratio to the YH35324 3 mg/kg, YH35324 6 mg/kg, or omalizumab group. [Part 2] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 6 mg/kg or placebo group. [Part 3] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 6 mg/kg or placebo group. | Drug: YH35324<br>* Subcutaneous injection of YH35324<br>|
| Active Comparator: Omalizumab<br>[Part 1] A total of 18 subjects will be randomized in a 1:1:1 ratio to the YH35324 3 mg/kg, YH35324 6 mg/kg, or omalizumab group. | Drug: Omalizumab<br>* Subcutaneous injection of Omalizumab<br>* Other names: Xolair® prefilled syringe 150 for injection;|
| Placebo Comparator: Placebo<br>[Part 2] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 6 mg/kg or placebo group. [Part 3] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 6 mg/kg or placebo group. | Drug: Placebo<br>* Subcutaneous injection of None of active ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and severity of adverse events (AEs) | To evaluate the safety and tolerability following single administration of YH35324 | Occurrence and severity of adverse events will be observed for 57 days after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum free IgE level | To evaluate the PD profile on serum IgE following single administration of YH35324 | Change in serum free IgE will be observed for 57 days after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GI-301, YH35324, Allergic disease, CSU, CINDU, Cold urticaria