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

Yuhan Corporation30 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Allergic Disease Chronic Spontaneous Urticaria Chronic Inducible Urticaria Cold Urticaria

Interventions

YH35324DRUG

Subcutaneous injection of YH35324

OmalizumabDRUG

Subcutaneous injection of Omalizumab

PlaceboDRUG

Subcutaneous injection of None of active ingredient

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female adults aged ≥ 19 to ≤ 75 years \[Parts 1 and 2 only\] * Diagnosis of CSU \[Part 2 only\] * Experience of inadequately uncontrolled CSU despite use of omalizumab \[Part 3 only\] * Diagnosis of chronic inducible urticaria (cold urticaria) Exclusion Criteria: * History of malignancy within 5 years from screening * Aspartate transaminase (AST) or alanine transaminase (ALT) level \&gt; 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 potential participation in a clinical trial.

Locations (9)

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, South Korea

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Occurrence and severity of adverse events (AEs)

To evaluate the safety and tolerability following single administration of YH35324

Time frame: Occurrence and severity of adverse events will be observed for 57 days after administration

Secondary Outcomes

Change in serum free IgE level

To evaluate the PD profile on serum IgE following single administration of YH35324

Time frame: Change in serum free IgE will be observed for 57 days after administration

Data from ClinicalTrials.gov

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