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

NCT05061524 | Completed Phase 1 DMC

• 1 other identifier: YH35324-101
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Atopic Healthy Subjects; Adult Subjects with Mild Allergic Diseases

Keywords

YH35324; GI-301; Allergic disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To evaluate the PK 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 will be observed for 113 days after administration

Other Outcomes (4)

• To explore the PD of YH35324

  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 will be observed for 57 days after administration

• To explore the immunogenicity of YH35324

  Incidence of serum Anti-YH35324 antibodies will be observed for 113 Days after administration

Study Arms (3)

YH35324

EXPERIMENTAL

* 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

Placebo

PLACEBO COMPARATOR

* 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

Xolair® for injection (Omalizumab)

ACTIVE COMPARATOR

* 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

Interventions

YH35324 DRUG

Subcutaneous injection of YH35324

YH35324

Placebo DRUG

Subcutaneous injection of None of active ingredient

Placebo

Omalizumab DRUG

Subcutaneous injection of Omalizumab

Also known as: Xolair® for injection

Xolair® for injection (Omalizumab)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \~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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (4)

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Asan Medical Center

Pungnap-tong, Seoul, 05505, South Korea

Location

Severance Hospital, Yonsei University Health System

Sinchon-dong, Seoul, 03722, South Korea

Location

Seoul National University Bundang Hospital

Gumi, Sungnamsi, 13620, South Korea

Location

MeSH Terms

Interventions

Omalizumab; Injections

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 29, 2021
• Study Start: September 26, 2021
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning 1 year and ending 5 years after all trial endpoints were assessed
• 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.

Locations

KR (4)