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Phase 2 Trial of HY209gel in Atopic Dermatitis Patients

Atopic Dermatitis Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of HY209 Gel in Patients With Mild to Moderate Atopic Dermatitis(AD)

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, multi-center, phase 2 study in patients with mild to moderate Atopic Dermatitis(AD), which consists of 2 parts.

Clinical Trial Description

Part 1 (2 cohorts): Total 33 subjects - Cohort A: 15 subjects (6 HY209gel 0.5%, 6 HY209gel 1%, and 3 placebo) - Cohort B: 9 subjects (6 HY209gel 2%, and 3 placebo) - Cohort C: 9 subjects (6 HY209gel 4%, and 3 placebo) Part 2 (3 treatment groups): Total 177 subjects - Low dose of HY209gel: 59 subjects - High dose of HY209gel: 59 subjects - Placebo (Vehicle): 59 subjects Part 1 is a dose-escalation part of HY209gel using lower doses of HY209gel (0.5% and 1%) with escalation (HY209gel 2% and 4%) to evaluate the pharmacokinetics(PK), safety, and tolerability of HY209gel treatment. Escalation to the next dose level will be decided by the Safety Monitoring Committee(SMC) that will review all available safety data of the planned dose level within the timeline specified on SMC charter after all enrolled subjects of each cohort complete 2-week treatment and determine the escalation to the next dose to be safe. Based on the interim analysis for 4-week safety and efficacy data collected from Part 1, two doses will be selected for use in Part 2, which will enroll up to 177 subjects in 3 treatment arms (59 subjects per treatment arm) to evaluate the efficacy and safety of HY209gel, compared to placebo (vehicle) for 8-week treatment period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06024499
Study type Interventional
Source Shaperon
Contact Shaperon Shaperon
Phone 82-2-6083-8315
Email seoh@shaperon.com
Status Recruiting
Phase Phase 2
Start date March 1, 2024
Completion date March 31, 2026
View Details
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