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Completed

NCT Number: NCT05960708

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

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.

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Key information

Conditions

Allergic Disease Chronic Disease Chronic Inducible Urticaria Chronic Spontaneous Urticaria Chronic Urticaria Cold Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hallym University Sacred Heart Hospital, Anyang-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 > 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.

Treatment and study plan

YH35324

Drug

Subcutaneous injection of YH35324

Omalizumab

Drug

Subcutaneous injection of Omalizumab

Other names: Xolair® prefilled syringe 150 for injection

Placebo

Drug

Subcutaneous injection of None of active ingredient

Primary outcomes

  1. Occurrence and severity of adverse events (AEs)

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

    To evaluate the safety and tolerability following single administration of YH35324

Secondary outcomes

  1. Change in serum free IgE level

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

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

Other outcomes

  1. Maximum Serum Concentration(Cmax)

    Time frame: Serum concentrations of YH35324 will be observed for 57 days after administration

    To evaluate the PK profile following single administration of YH35324

  2. Area Under the Serum Concentration-Time Curve from Zero to the Time of the Last Quantitative Concentration (AUClast)

    Time frame: Serum concentrations of YH35324 will be observed for 57 days after administration

    To evaluate the PK profile following single administration of YH35324

  3. Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUCinf)

    Time frame: Serum concentrations of YH35324 will be observed for 57 days after administration

    To evaluate the PK profile following single administration of YH35324

  4. Time to Maximum Serum Concentration (Tmax)

    Time frame: Serum concentrations of YH35324 will be observed for 57 days after administration

    To evaluate the PK profile following single administration of YH35324

  5. Terminal Elimination Rate Constant, Apparent Terminal Elimination Half-life (t1/2)

    Time frame: Serum concentrations of YH35324 will be observed for 57 days after administration

    To evaluate the PK profile following single administration of YH35324

  6. Apparent Serum Clearance (CL/F)

    Time frame: Serum concentrations of YH35324 will be observed for 57 days after administration

    To evaluate the PK profile following single administration of YH35324

  7. Apparent Volume of Distribution (Vz/F)

    Time frame: Serum concentrations of YH35324 will be observed for 57 days after administration

    To evaluate the PK profile following single administration of YH35324

  8. Change in serum total IgE level

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

    To evaluate the exploratory PD profile following single administration of YH35324

  9. Change in FcƐRI expression on basophil surface

    Time frame: Change in FcƐRI expression on basophil surface will be observed for 57 days after administration

    To evaluate the exploratory PD profile following single administration of YH35324

  10. Change in serum soluble FcƐRI concentration

    Time frame: Change in serum soluble FcƐRI concentration will be observed for 57 days after administration

    To evaluate the exploratory PD profile following single administration of YH35324

  11. Change in serum Mas-related G protein-coupled receptor-X2 (MRGPRX2) concentration

    Time frame: Change in serum Mas-related G protein-coupled receptor-X2 (MRGPRX2) concentration will be observed for 57 days after administration

    To evaluate the exploratory PD profile following single administration of YH35324

  12. [Parts 1 and 2 only] Change in Basophil Histamine Release Assay (BHRA)

    Time frame: Change in Basophil Histamine Release Assay (BHRA) will be observed for 57 days after administration

    To evaluate the exploratory PD profile following single administration of YH35324

  13. Change in the Urticaria Control Test (UCT) score

    Time frame: Change in the Urticaria Control Test (UCT) score will be observed for 57 days after administration

    To explore the clinical efficacy following single administration of YH35324

    • Urticaria Control Test score
    • minimum value: 0 / maximum value: 16
    • Higher scores mean a better outcome

  14. Rate of Use of rescue medications

    Time frame: Use of rescue medications will be observed for 57 days after administration

    To explore the clinical efficacy following single administration of YH35324 for using rescue medications diary

  15. [Parts 1 and 2 only] Change in weekly Hive Severity Score 7 (HSS7)

    Time frame: Change in weekly Hive Severity Score 7 (HSS7) will be observed for 57 days after administration

    To explore the clinical efficacy following single administration of YH35324

    • Hive Severity Score 7
    • minimum value: 0 / maximum value: 21
    • Higher scores mean a worse outcome

  16. [Parts 1 and 2 only] Change in weekly Itch Severity Score 7 (ISS7)

    Time frame: Change in weekly Itch Severity Score 7 (ISS7) will be observed for 57 days after administration

    To explore the clinical efficacy following single administration of YH35324

    • Itch Severity Score 7
    • minimum value: 0 / maximum value: 21
    • Higher scores mean a worse outcome

  17. [Parts 1 and 2 only] Change in weekly Urticaria Activity Score 7 (UAS7)

    Time frame: Change in weekly Urticaria Activity Score 7 (UAS7) will be observed for 57 days after administration

    To explore the clinical efficacy following single administration of YH35324

    • Urticaria Activity Score 7
    • minimum value: 0 / maximum value: 42
    • Higher scores mean a worse outcome

  18. [Part 3 only] Change in Critical Temperature Thresholds (CTT) in response to the challenge test (TempTest® 4)

    Time frame: Change in Critical Temperature Thresholds (CTT) in response to the challenge test (TempTest® 4) will be observed for 57 days after administration

    To explore the clinical efficacy following single administration of YH35324

  19. [Part 3 only] Change in the Peak Pruritus Numerical Rating Scale (PP-NRS) score after the challenge test (TempTest® 4)

    Time frame: Change in the Peak Pruritus Numerical Rating Scale (PP-NRS) score after the challenge test (TempTest® 4) will be observed for 57 days after administration

    To explore the clinical efficacy following single administration of YH35324

    • Peak Pruritus Numerical Rating Scale
    • minimum value: 0 / maximum value: 10
    • Higher scores mean a worse outcome

  20. Incidence of serum anti-YH35324 antibodies

    Time frame: Incidence of serum anti-YH35324 antibodies will be observed for 57 days after administration

    To explore the immunogenicity following single administration of YH35324

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo/Active Controlled, Single Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of YH35324 in Patients with Various Allergic Diseases

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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