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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05061524

Enrollment

Registered

2021-09-29

Start date

2021-09-26

Completion date

2023-01-25

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Subjects with Mild Allergic Diseases, Atopic Healthy Subjects

Keywords

YH35324, GI-301, Allergic disease

Brief summary

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.

Detailed 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.

Interventions

DRUGYH35324

Subcutaneous injection of YH35324

DRUGPlacebo

Subcutaneous injection of None of active ingredient

DRUGOmalizumab

Subcutaneous injection of Omalizumab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the safety and tolerability following single administration of YH35324	Occurrence and severity of adverse events will be observed for 113 days after administration	Occurrence and severity of adverse events (AEs)

Secondary

Measure	Time frame	Description
To evaluate the PK of YH35324	Serum concentrations of YH35324 will be observed for 113 days after administration	Serum concentrations of YH35324
To evaluate the PD of YH35324	Change in serum Free/Total IgE level will be observed for 113 days after administration	Change in serum Free/Total IgE level

Other

Measure	Time frame	Description
To explore the PD of YH35324	Changes in FcεRI expression will be observed for 57days after administration	Changes in FcεRI expression
To explore inhibition on allergens (allergy antigens) of YH35324	Changes in allergen-induced skin prick wheal response will be observed for 57 days after administration	Changes in allergen-induced skin prick wheal response
To explore the immunogenicity of YH35324	Incidence of serum Anti-YH35324 antibodies will be observed for 113 Days after administration	Incidence of serum Anti-YH35324 antibodies

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026