NCT03492398

A Phase I Study of HY209 Gel in Healthy Male Volunteers for Atopic Dermatitis

A Randomized, Double-blind, Placebo-controlled Single Multiple Dosing, Dose Escalation Phase I Clinical Trial to Investigate HY209 Gel in Healthy Male Volunteers as a Possible Treatment Option for Atopic Dermatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Shaperon · Industry
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A randomized, double-blind, placebo-controlled single and multiple dosing, dose escalation phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209 gel after transdermal administration in healthy male volunteers as a possible treatment option for atopic dermatitis

Detailed description

A composition containing G Protein Coupled Receptor 19(GPCR19) agonist HY209 and a derivative thereof is found to have a considerable effect in the treatment of atopic dermatitis and is proposed as a pharmaceutical ingredient for prevention, treatment and improvement of atopic dermatitis. The GPCR19 agonist, HY209, is superior to conventional steroid ointment and immunosuppressant ointment in the treatment and improvement of allergic dermatitis. It directly reduces the amount of serum immunoglobulin E, which is a major factor of allergic dermatitis, It increases the T helper type 1(TH1) cytokines that alleviate allergic dermatitis pathologies, reduces the T helper type 2(TH2) cytokines that aggravate allergic dermatitis pathologies, and reduces the infiltration of mast cells, eosinophils and neutrophils into the dermal cells. Thus it can be utilized as a therapeutic drug composition for atopic dermatitis.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	HY209	6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.

Timeline

• Start date: 2018-01-29
• Primary completion: 2019-03-21
• Completion: 2019-05-28
• First posted: 2018-04-10
• Last updated: 2021-01-29
• Results posted: 2020-10-19

Locations

1 site across 1 country: South Korea