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

  • End date
    Dec 20, 2022
  • participants needed
  • sponsor
    Yuhan Corporation
Updated on 22 March 2022
Accepts healthy volunteers


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.


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.

Condition Atopic Healthy Subjects, Adult Subjects With Mild Allergic Diseases
Treatment Placebo, omalizumab, YH35324
Clinical Study IdentifierNCT05061524
SponsorYuhan Corporation
Last Modified on22 March 2022


Yes No Not Sure

Inclusion Criteria

~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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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