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

Last updated: November 21, 2024
Sponsor: Yuhan Corporation
Overall Status: Completed

Phase

1

Condition

Hives (Urticaria)

Allergy (Pediatric)

Urticaria

Treatment

Omalizumab

Placebo

YH35324

Clinical Study ID

NCT05960708
YH35324-103
  • Ages 19-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • History of malignancy within 5 years from screening

  • Aspartate transaminase (AST) or alanine transaminase (ALT) level > 2 X theupper 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.

Study Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Omalizumab
Phase: 1
Study Start date:
August 23, 2023
Estimated Completion Date:
September 13, 2024

Study Description

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.

Connect with a study center

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do 14068
    Korea, Republic of

    Site Not Available

  • Hallym University Dongtan Sacred Heart Hospital

    Hwaseong-si, Gyeonggi-do 18450
    Korea, Republic of

    Site Not Available

  • CHA Bundang Medical Center

    Seongnam-si, Gyeonggi-do 13496
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon-si, Gyeonggi-do 16499
    Korea, Republic of

    Site Not Available

  • Dong-a University hospital

    Busan, 49201
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

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