- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03492398
A Phase I Study of HY209 Gel in Healthy Male Volunteers for Atopic Dermatitis (Shaperon)
January 12, 2021 updated by: 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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
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
|
6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Other Names:
|
EXPERIMENTAL: Cohort A HY209 0.1% gel
single dose of HY209 0.1% gel or single dose of placebo
|
6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Other Names:
|
EXPERIMENTAL: Cohort A HY209 0.3% gel
single dose of HY209 0.3% gel or single dose of placebo
|
6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Other Names:
|
EXPERIMENTAL: Cohort A HY209 0.5% gel
single dose of HY209 0.5% gel or single dose of placebo
|
6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Other Names:
|
EXPERIMENTAL: Cohort B HY209 0.1% gel
multiple dose of HY209 0.1% gel or multiple dose of placebo
|
6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Other Names:
|
EXPERIMENTAL: Cohort B HY209 0.3% gel
multiple dose of HY209 0.3% gel or multiple dose of placebo
|
6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Other Names:
|
EXPERIMENTAL: Cohort B HY209 0.5% gel
multiple dose of HY209 0.5% gel or multiple dose of placebo
|
6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment Emergent Adverse Events
Time Frame: upto Day 8(single dosing), upto Day 38(multiple dosing)
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Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
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upto Day 8(single dosing), upto Day 38(multiple dosing)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kyungsang Yu, Ph.D., Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atopic Dermatitis
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Catalysis SLCompletedAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related Conditions | Atopic Dermatitis \(AD\)Serbia
-
Jacob Pontoppidan ThyssenThe Novo Nordic FoundationRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis FlareDenmark
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ShaperonNot yet recruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis of Scalp
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University of California, San FranciscoSanofi; Regeneron PharmaceuticalsRecruitingEczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related ConditionsUnited States
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PfizerActive, not recruitingEczema | Atopic Dermatitis | Eczema, Atopic | Atopic Dermatitis, UnspecifiedUnited States, Canada, Czechia, Poland
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AmgenCompletedDermatitis, Atopic DermatitisCanada, United States, Japan
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Hadassah Medical OrganizationUnknownATOPIC DERMATITIS
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SanofiCompletedAtopic Dermatitis | Dermatitis AtopicChina
-
SanofiCompletedDermatitis AtopicSaudi Arabia, Kuwait, United Arab Emirates
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National Institute of Allergy and Infectious Diseases...Atopic Dermatitis Research NetworkCompletedAtopic Dermatitis (AD) | Non-atopic Healthy ControlsUnited States
Clinical Trials on HY209
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ShaperonCompletedAtopic DermatitisKorea, Republic of