drugset / Trial / NCT05061524

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

NCT05061524

Phase 1 Completed 68 enrolled Yuhan Corporation
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2021-09-26
Primary completion
2023-01-25
Completion
2023-01-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Omalizumab Monoclonal antibody 300 mg Subcutaneous
Subject YH35324 Unknown 0.3 mg/kg Subcutaneous
Subject YH35324 Unknown 1 mg/kg Subcutaneous
Subject YH35324 Unknown 3 mg/kg Subcutaneous
Subject YH35324 Unknown 6 mg/kg Subcutaneous
Subject YH35324 Unknown 9 mg/kg Subcutaneous