A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects With Mild Allergic Diseases

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability, PK, and PD following subcutaneous injections of YH35324 in atopic healthy subjects or adult subjects with mild allergic diseases. Eligible subjects will be randomized to the YH35324 group, the placebo group, or the omalizumab group.

Detailed Description
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YH35324 is a drug under development as a novel therapeutic agent for various IgE-mediated allergic diseases. Since YH35324 has a high binding affinity to human IgE, it prevents serum IgE from binding to receptors on mast cells and basophil, thereby inhibiting histamine release caused by degranulation when exposed to allergens Based on its non-clinical study results, this study aims to evaluate the safety, tolerability, PK, and PD following subcutaneous injections of YH35324 in atopic healthy subjects or subjects with mild allergic diseases.

Official Title
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A First-in-Human, Randomized, Double-Blind, Placebo/Active Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following Subcutaneous Injections of YH35324 in Atopic Healthy Subjects or Subjects With Mild Allergic Diseases

Conditions
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Atopic Healthy Subjects, Adult Subjects With Mild Allergic Diseases

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 55 years old, Atopic Healthy Subjects or Subjects With Mild Allergic Diseases Serum total IgE level of 30 to 700 IU/mL or > 700 IU/mL Signed the informed consent form Exclusion Criteria: Hyperimmunoglobulin E syndrome or malignancy Positive drug screen result AST or ALT > 1.5 * Upper normal range eGFR < 60mL/min/1.73m2 Allergy immunotherapy initiated or Administration of a live vaccine within 3 months prior to randomization History of participation in another clinical trial within 6 months prior to randomization

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YH35324<br>Part A: A single dose of the YH35324 will be administered subcutaneously in 5 dose groups (0.3, 1, 3, 6, and 9 mg/kg), and a dose will be escalated in a stepwise manner from low to high doses Part B: A single dose of the YH35324 will be administered subcutaneously. The dose of YH35324 will be determined after the safety, tolerability, PK, and PD data in Part A are reviewed | Drug: YH35324<br>* Subcutaneous injection of YH35324<br>|
| Placebo Comparator: Placebo<br>Part A: A single dose of the Placebo will be administered subcutaneously in 5 Cohorts(Dose groups=0.3, 1, 3, 6, and 9 mg/kg), and a dose will be escalated in a stepwise manner from low to high doses Part B: Placebo is not administered in Part B | Drug: Placebo<br>* Subcutaneous injection of None of active ingredient<br>|
| Active Comparator: Xolair® for injection (Omalizumab)<br>Part A: A single fixed dose of the Omalizumab 300mg will be administered subcutaneously in 4 Cohorts(Dose groups of YH35324=1, 3, 6, and 9 mg/kg) Part B: A single dose of the Omalizumab 300mg will be administered subcutaneously. | Drug: Omalizumab<br>* Subcutaneous injection of Omalizumab<br>* Other names: Xolair® for injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability following single administration of YH35324 | Occurrence and severity of adverse events (AEs) | Occurrence and severity of adverse events will be observed for 113 days after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the PK of YH35324 | Serum concentrations of YH35324 | Serum concentrations of YH35324 will be observed for 113 days after administration | 
| To evaluate the PD of YH35324 | Change in serum Free/Total IgE level | Change in serum Free/Total IgE level will be observed for 113 days after administration | 

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