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

Y

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

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

Trial contacts and locations

9

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Central trial contact

Eunji Song; JungWook Ahn

Data sourced from clinicaltrials.gov

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