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

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

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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