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Completed

NCT Number: NCT05061524

A FIH Study 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.

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Key information

Conditions

Atopic Healthy Subjects Adult Subjects with Mild Allergic Diseases

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ajou University Hospital, Suwon, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

YH35324

Drug

Subcutaneous injection of YH35324

Placebo

Drug

Subcutaneous injection of None of active ingredient

Omalizumab

Drug

Subcutaneous injection of Omalizumab

Other names: Xolair® for injection

Primary outcomes

  1. To evaluate the safety and tolerability following single administration of YH35324

    Time frame: Occurrence and severity of adverse events will be observed for 113 days after administration

    Occurrence and severity of adverse events (AEs)

Secondary outcomes

  1. To evaluate the PK of YH35324

    Time frame: Serum concentrations of YH35324 will be observed for 113 days after administration

    Serum concentrations of YH35324

  2. To evaluate the PD of YH35324

    Time frame: Change in serum Free/Total IgE level will be observed for 113 days after administration

    Change in serum Free/Total IgE level

Other outcomes

  1. To explore the PD of YH35324

    Time frame: Changes in FcεRI expression will be observed for 57days after administration

    Changes in FcεRI expression

  2. To explore inhibition on allergens (allergy antigens) of YH35324

    Time frame: Changes in allergen-induced skin prick wheal response will be observed for 57 days after administration

    Changes in allergen-induced skin prick wheal response

  3. To explore the immunogenicity of YH35324

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

    Incidence of serum Anti-YH35324 antibodies

  4. To explore inhibition on allergens (allergy antigens) of YH35324

    Time frame: Changes in allergen-induced serum allergen specific IgE level will be observed for 57 days after administration

    Changes in serum allergen specific IgE level

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2021
Registry last updated
Dec 3, 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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