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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

HY209

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Arm Label

Cohort A HY209 0.05% gel

Cohort A HY209 0.1% gel

Cohort A HY209 0.3% gel

Cohort A HY209 0.5% gel

Cohort B HY209 0.1% gel

Cohort B HY209 0.3% gel

Cohort B HY209 0.5% gel

Arm Description

single dose of HY209 0.05% gel or single dose of placebo

single dose of HY209 0.1% gel or single dose of placebo

single dose of HY209 0.3% gel or single dose of placebo

single dose of HY209 0.5% gel or single dose of placebo

multiple dose of HY209 0.1% gel or multiple dose of placebo

multiple dose of HY209 0.3% gel or multiple dose of placebo

multiple dose of HY209 0.5% gel or multiple dose of placebo

Outcomes

Primary Outcome Measures

Incidence of Treatment Emergent Adverse Events

Number of participants with abnormal laboratory values and/or adverse events that are related to treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT03492398

First Posted

February 15, 2018

Last Updated

January 12, 2021

Sponsor

Shaperon

1. Study Identification

Unique Protocol Identification Number

NCT03492398

Brief Title

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

Acronym

Shaperon

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

January 29, 2018 (Actual)

Primary Completion Date

March 21, 2019 (Actual)

Study Completion Date

May 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shaperon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

atopic dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

A randomized, double blind, placebo-controlled, single and multiple dosing, dose escalation study

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A HY209 0.05% gel

Arm Type

Experimental

Arm Description

single dose of HY209 0.05% gel or single dose of placebo

Arm Title

Cohort A HY209 0.1% gel

Arm Type

Experimental

Arm Description

single dose of HY209 0.1% gel or single dose of placebo

Arm Title

Cohort A HY209 0.3% gel

Arm Type

Experimental

Arm Description

single dose of HY209 0.3% gel or single dose of placebo

Arm Title

Cohort A HY209 0.5% gel

Arm Type

Experimental

Arm Description

single dose of HY209 0.5% gel or single dose of placebo

Arm Title

Cohort B HY209 0.1% gel

Arm Type

Experimental

Arm Description

multiple dose of HY209 0.1% gel or multiple dose of placebo

Arm Title

Cohort B HY209 0.3% gel

Arm Type

Experimental

Arm Description

multiple dose of HY209 0.3% gel or multiple dose of placebo

Arm Title

Cohort B HY209 0.5% gel

Arm Type

Experimental

Arm Description

multiple dose of HY209 0.5% gel or multiple dose of placebo

Intervention Type

Drug

Intervention Name(s)

HY209

Other Intervention Name(s)

HY209 gel

Intervention Description

6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.

Primary Outcome Measure Information:

Title

Incidence of Treatment Emergent Adverse Events

Description

Number of participants with abnormal laboratory values and/or adverse events that are related to treatment

Time Frame

upto Day 8(single dosing), upto Day 38(multiple dosing)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyungsang Yu, Ph.D.

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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