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

Yuhan Corporation68 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atopic Healthy Subjects Adult Subjects with Mild Allergic Diseases

Interventions

YH35324DRUG

Subcutaneous injection of YH35324

PlaceboDRUG

Subcutaneous injection of None of active ingredient

OmalizumabDRUG

Subcutaneous injection of Omalizumab

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Asan Medical Center

Pungnap-tong, Seoul, South Korea

Severance Hospital, Yonsei University Health System

Sinchon-dong, Seoul, South Korea

Seoul National University Bundang Hospital

Gumi, Sungnamsi, South Korea

Outcomes

Primary Outcomes

To evaluate the safety and tolerability following single administration of YH35324

Occurrence and severity of adverse events (AEs)

Time frame: Occurrence and severity of adverse events will be observed for 113 days after administration

Secondary Outcomes

To evaluate the PK of YH35324

Serum concentrations of YH35324

Time frame: 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

Time frame: Change in serum Free/Total IgE level will be observed for 113 days after administration

Data from ClinicalTrials.gov

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