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

NCT05061524 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-12-03

No results posted yet for this study

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.

Conditions

  • Atopic Healthy Subjects
  • Adult Subjects with Mild Allergic Diseases

Interventions

DRUG

YH35324

Subcutaneous injection of YH35324

DRUG

Placebo

Subcutaneous injection of None of active ingredient

DRUG

Omalizumab

Subcutaneous injection of Omalizumab

Sponsors & Collaborators

  • Yuhan Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05061524 on ClinicalTrials.gov