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

NCT ID: NCT05061524

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-26

Study Completion Date

2023-01-25

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.

Conditions

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Atopic Healthy Subjects Adult Subjects with Mild Allergic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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YH35324

* 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

Group Type EXPERIMENTAL

YH35324

Intervention Type DRUG

Subcutaneous injection of YH35324

Placebo

* 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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous injection of None of active ingredient

Xolair® for injection (Omalizumab)

* 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.

Group Type ACTIVE_COMPARATOR

Omalizumab

Intervention Type DRUG

Subcutaneous injection of Omalizumab

Interventions

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YH35324

Subcutaneous injection of YH35324

Intervention Type DRUG

Placebo

Subcutaneous injection of None of active ingredient

Intervention Type DRUG

Omalizumab

Subcutaneous injection of Omalizumab

Intervention Type DRUG

Other Intervention Names

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Xolair® for injection

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Site Status

Asan Medical Center

Pungnap-tong, Seoul, South Korea

Site Status

Severance Hospital, Yonsei University Health System

Sinchon-dong, Seoul, South Korea

Site Status

Seoul National University Bundang Hospital

Gumi, Sungnamsi, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YH35324-101

Identifier Type: -

Identifier Source: org_study_id