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

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

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

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: HY209

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male aged from 20 to 50 at screening test
• Weight 45kg ~ 90kg with BMI 17kg/m2 ~ 27kg/m2
• No skin diseases, no skin damages(scars, tattoo, etc), no hairy skin

Exclusion Criteria:

• Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to generic drugs (aspirin, antibiotics, etc.)
• Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic diseases, mental diseases, especially hemorrhagic diseases (hemophilia, von Willebrand disease, etc.), cardiovascular diseases (coronary artery disease, Congestive heart failure, arrhythmia, cerebrovascular disease, etc.) or who have a history of those diseases
• Those who had clinical symptoms suspected of acute infectious disease within 2 weeks before the scheduled date of the first administration, or whose temperature measured by the screening test (eardrum) was 38.0 ° C or higher
• Those who have taken any prescription drugs, herbal medicines, crude drugs within 2 weeks before the scheduled date of administration of the medicines for clinical trials , or over-the-counter medicines or vitamin preparations within 1 week.
• Those who have a history of substance abuse, or positive urine screening tests (cannabinoid, opiates, amphetamine, cocaine, barbiturate, benzodiazepine)
• Those who have a history of smoking within 3 months (However, if they quit smoking three months before the first scheduled medication, they are eligible for selection)
• Those who have been found to be positive in serological tests (HBs antigen, hepatitis C virus antibody and HIV antibody)
• Those who drink continuously (above 21 units / week, 1 unit = 10 g of pure alcohol)
• Those who have been taking medicines by participating in other clinical trials or bioequivalence studies within 3 months prior to the date of first dosing
• Those who have been bleeding, blood drawings or blood donation of 400mL or more within 8 weeks before the scheduled date of administration of the drug for clinical trials

• Those who have vital signs measured at sitting position after the break for more than 3 minutes,

  • Low blood pressure (systolic blood pressure <90 mmHg, diastolic blood pressure <50 mmHg)
  • High blood pressure (systolic blood pressure greater than 150 mmHg, diastolic blood pressure greater than 100 mmHg)
• Test subjects who are deemed unsuitable for participating in clinical trials due to clinical laboratory tests, ECG results, or other reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort A HY209 0.05% gel; single dose of HY209 0.05% gel or single dose of placebo	Drug: HY209; 6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.; Other Names: HY209 gel
EXPERIMENTAL: Cohort A HY209 0.1% gel; single dose of HY209 0.1% gel or single dose of placebo	Drug: HY209; 6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.; Other Names: HY209 gel
EXPERIMENTAL: Cohort A HY209 0.3% gel; single dose of HY209 0.3% gel or single dose of placebo	Drug: HY209; 6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.; Other Names: HY209 gel
EXPERIMENTAL: Cohort A HY209 0.5% gel; single dose of HY209 0.5% gel or single dose of placebo	Drug: HY209; 6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.; Other Names: HY209 gel
EXPERIMENTAL: Cohort B HY209 0.1% gel; multiple dose of HY209 0.1% gel or multiple dose of placebo	Drug: HY209; 6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.; Other Names: HY209 gel
EXPERIMENTAL: Cohort B HY209 0.3% gel; multiple dose of HY209 0.3% gel or multiple dose of placebo	Drug: HY209; 6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.; Other Names: HY209 gel
EXPERIMENTAL: Cohort B HY209 0.5% gel; multiple dose of HY209 0.5% gel or multiple dose of placebo	Drug: HY209; 6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.; Other Names: HY209 gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment Emergent Adverse Events	Number of participants with abnormal laboratory values and/or adverse events that are related to treatment	upto Day 8(single dosing), upto Day 38(multiple dosing)

Collaborators and Investigators

• Sponsor: Shaperon
• Investigators: Principal Investigator: Kyungsang Yu, Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2018
• Primary Completion (ACTUAL): March 21, 2019
• Study Completion (ACTUAL): May 28, 2019

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: April 6, 2018
• First Posted (ACTUAL): April 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: atopic dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: HY209-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No