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Trial record 87 of 740 for:    "Dermatitis, Atopic"

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

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ClinicalTrials.gov Identifier: NCT03492398
Recruitment Status : Enrolling by invitation
First Posted : April 10, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Shaperon

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: HY209 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, double blind, placebo-controlled, single and multiple dosing, dose escalation study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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 HY209 0.05% gel and 2 subjects will be assigned to placebo.

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 HY209 0.1 % gel and 2 subjects will be assigned to placebo.

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 HY209 0.3% gel and 2 subjects will be assigned to placebo.

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 HY209 0.5% gel and 2 subjects will be assigned to placebo.

Experimental: Cohort B HY209 0.05% gel
multiple dose of HY209 0.05% gel or multiple dose of placebo
Drug: HY209
6 subjects will be assigned to HY209 0.05% gel and 2 subjects will be assigned to placebo. The trial drug or placebo will be applied on the back of each subject once a day from Day 1 to Day 28.

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 HY209 0.1% gel and 2 subjects will be assigned to placebo. The trial drug or placebo will be applied on the back of each subject once a day from Day 1 to Day 28.

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 HY209 0.3% gel and 2 subjects will be assigned to placebo. The trial drug or placebo will be applied on the back of each subject once a day from Day 1 to Day 28.




Primary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events [ Time Frame: upto Day 8(single dosing), upto Day 38(multiple dosing) ]
    Number of participants with abnormal laboratory values and/or adverse events that are related to treatment


Secondary Outcome Measures :
  1. Cmax of HY209 in a Single Administration Period [ Time Frame: upto Day 8 ]
  2. AUCinf of HY209 in a Single Administration Period [ Time Frame: upto Day 8 ]
  3. Tmax of HY209 in a Single Administration Period [ Time Frame: upto Day 8 ]
  4. t1/2 of HY209 in a Single Administration Period [ Time Frame: upto Day 8 ]
  5. Clearance of HY209 in a Single Administration Period [ Time Frame: upto Day 8 ]
  6. Cmax,ss of HY209 in a Multiple Administration Period [ Time Frame: upto Day 38 ]
  7. Cmin,ss of HY209 in a Multiple Administration Period [ Time Frame: upto Day 38 ]
  8. AUCτ,ss of HY209 in a Multiple Administration Period [ Time Frame: upto Day 38 ]
  9. Tmax,ss of HY209 in a Multiple Administration Period [ Time Frame: upto Day 38 ]
  10. t1/2ss of HY209 in a Multiple Administration Period [ Time Frame: upto Day 38 ]
  11. Clearance of HY209 in a Multiple Administration Period [ Time Frame: upto Day 38 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492398


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Shaperon
Investigators
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Principal Investigator: Kyungsang Yu, Ph.D. Seoul National University Hospital

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Responsible Party: Shaperon
ClinicalTrials.gov Identifier: NCT03492398     History of Changes
Other Study ID Numbers: HY209-202
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shaperon:
atopic dermatitis

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases