Overview

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

Status:
Recruiting

Trial end date:
2024-08-26

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Yuhan Corporation

Treatments:

Omalizumab

Criteria

Inclusion Criteria:

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

[Parts 1 and 2 only]

- Diagnosis of CSU at least 6 months prior to screening

- Diagnosis of CSU inadequately controlled on 2nd-generation H1 antihistamines at the
time of randomization

[Part 2 only]

- Experience of inadequately uncontrolled CSU despite use of omalizumab

[Part 3 only]

- Diagnosis of chronic inducible urticaria (cold urticaria) at least 3 months prior to
screening

- Diagnosis of chronic inducible urticaria (cold urticaria) inadequately controlled on
2nd-generation H1 antihistamines at the time of randomization

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's
potential participation in a clinical trial.