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

Y

Yuhan

Status and phase

Completed
Phase 1

Conditions

Adult Subjects with Mild Allergic Diseases
Atopic Healthy Subjects

Treatments

Drug: YH35324
Drug: Placebo
Drug: Omalizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05061524
YH35324-101

Details and patient eligibility

About

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.

Full description

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.

Enrollment

68 patients

Sex

All

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

68 participants in 3 patient groups, including a placebo group

YH35324
Experimental group
Description:
* 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
Treatment:
Drug: YH35324
Placebo
Placebo Comparator group
Description:
* 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
Treatment:
Drug: Placebo
Xolair® for injection (Omalizumab)
Active Comparator group
Description:
* 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.
Treatment:
Drug: Omalizumab

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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