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

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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Healthy Subjects; Adult Subjects with Mild Allergic Diseases
• Intervention / Treatment: Drug: YH35324; Drug: Placebo; Drug: Omalizumab

Detailed Description

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
• Enrollment (Actual): 68
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital
  • Seoul
    • Pungnap-tong, Seoul, Korea, Republic of, 05505
      • Asan Medical Center
    • Sinchon-dong, Seoul, Korea, Republic of, 03722
      • Severance Hospital, Yonsei University Health System
  • Sungnamsi
    • Gumi, Sungnamsi, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: YH35324; Subcutaneous injection of YH35324
Placebo Comparator: 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	Drug: Placebo; Subcutaneous injection of None of active ingredient
Active Comparator: 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.	Drug: Omalizumab; Subcutaneous injection of Omalizumab; Other Names: Xolair® for injection

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore the PD of YH35324	Changes in FcεRI expression	Changes in FcεRI expression will be observed for 57days after administration
To explore inhibition on allergens (allergy antigens) of YH35324	Changes in allergen-induced skin prick wheal response	Changes in allergen-induced skin prick wheal response will be observed for 57 days after administration
To explore the immunogenicity of YH35324	Incidence of serum Anti-YH35324 antibodies	Incidence of serum Anti-YH35324 antibodies will be observed for 113 Days after administration
To explore inhibition on allergens (allergy antigens) of YH35324	Changes in serum allergen specific IgE level	Changes in allergen-induced serum allergen specific IgE level will be observed for 57 days after administration

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2021
• Primary Completion (Actual): January 25, 2023
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: GI-301; YH35324; Allergic disease
• Additional Relevant MeSH Terms: Respiratory System Agents; Anti-Asthmatic Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: YH35324-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to yhcho@yuhan.co.kr.

A summary of the study results will be posted in the publicly accessible database (i.e. clinicaltrials.gov) no later than 1 year after the study's primary completion date.

• IPD Sharing Time Frame: Beginning 1 year and ending 5 years after all trial endpoints were assessed
• IPD Sharing Access Criteria: Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to yhcho@yuhan.co.kr.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No