A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases

Yuhan

Status and phase: Completed; Phase 1

Conditions: Chronic Inducible Urticaria; Allergic Disease; Cold Urticaria; Chronic Spontaneous Urticaria

Treatments: Drug: Omalizumab; Drug: YH35324; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05960708

YH35324-103

Details and patient eligibility

About

This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following a single subcutaneous injection of YH35324 in subjects with various allergic diseases.

Full description

This drug(YH35324) is currently under development as a novel therapeutic agent for various IgE-mediated allergic diseases. Since YH35324 exhibits high binding affinity to human IgE, it prevents serum IgE from binding to receptors on mast cells and basophils, thereby inhibiting histamine release via degranulation following allergen exposures. In addition, YH35324 suppresses autoantibody-dependent effector cell activation by blocking anti-FcεRIα autoantibodies. This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following a single subcutaneous injection of YH35324 in subjects with various allergic diseases.

Enrollment: 30 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female adults aged ≥ 19 to ≤ 75 years

[Parts 1 and 2 only]

• Diagnosis of CSU

[Part 2 only]

• Experience of inadequately uncontrolled CSU despite use of omalizumab

[Part 3 only]

• Diagnosis of chronic inducible urticaria (cold urticaria)

Exclusion criteria

• History of malignancy within 5 years from screening
• Aspartate transaminase (AST) or alanine transaminase (ALT) level > 2 X the upper limit of normal

[Parts 1 and 2 only]

• Chronic urticaria with clear etiology other than CSU

[Part 3 only]

• Chronic urticaria other than studied chronic inducible urticaria (cold urticaria)

The above information is not intended to contain all considerations relevant to a patient potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

YH35324

Experimental group

Description:

\[Part 1\] A total of 18 subjects will be randomized in a 1:1:1 ratio to the YH35324 A mg/kg, YH35324 B mg/kg, or omalizumab group. \[Part 2\] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 B mg/kg or placebo group. \[Part 3\] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 B mg/kg or placebo group.

Treatment:

Drug: YH35324

Omalizumab

Active Comparator group

Description:

\[Part 1\] A total of 18 subjects will be randomized in a 1:1:1 ratio to the YH35324 A mg/kg, YH35324 B mg/kg, or omalizumab group.

Treatment:

Drug: Omalizumab

Placebo

Placebo Comparator group

Description:

\[Part 2\] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 B mg/kg or placebo group. \[Part 3\] A total of 9 subjects will be randomized in a 2:1 ratio to the YH35324 B mg/kg or placebo group.

Treatment:

Drug: Placebo