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

Sponsor
Yuhan Corporation
Study ID
NCT05061524
Phase
PHASE1
Status
Completed

Conditions

  • Adult Subjects with Mild Allergic Diseases
  • Atopic Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • YH35324 — DRUG
    Subcutaneous injection of YH35324
  • Placebo — DRUG
    Subcutaneous injection of None of active ingredient
  • Omalizumab — DRUG
    Subcutaneous injection of Omalizumab

Study Details

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.

Key Dates

Start date
Sep 26, 2021
Status verified
Nov 2024
Primary completion
Jan 25, 2023
Completion
Jan 25, 2023

Study Design

Enrollment
68 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: YH35324
    * Part A: A single dose of the YH35324 will be administered subcutaneously in 5 dose groups (0.3, 1, 3, 6, and 9 mg/kg), and a dose will be escalated in a stepwise manner from low to high doses * Part B: A single dose of the YH35324 will be administered subcutaneously. The dose of YH35324 will be determined after the safety, tolerability, PK, and PD data in Part A are reviewed
  • Placebo Comparator: Placebo
    * Part A: A single dose of the Placebo will be administered subcutaneously in 5 Cohorts(Dose groups=0.3, 1, 3, 6, and 9 mg/kg), and a dose will be escalated in a stepwise manner from low to high doses * Part B: Placebo is not administered in Part B
  • Active Comparator: Xolair® for injection (Omalizumab)
    * Part A: A single fixed dose of the Omalizumab 300mg will be administered subcutaneously in 4 Cohorts(Dose groups of YH35324=1, 3, 6, and 9 mg/kg) * Part B: A single dose of the Omalizumab 300mg will be administered subcutaneously.

Primary Outcome Measure

To evaluate the safety and tolerability following single administration of YH35324 [ Time Frame: Occurrence and severity of adverse events will be observed for 113 days after administration ]