Atopic Dermatitis
Conditions
Keywords
atopic dermatitis
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.
Interventions
DRUGHY209
6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Sponsors
Shaperon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A randomized, double blind, placebo-controlled, single and multiple dosing, dose escalation study
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events | 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 |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort A Placebo single dose of placebo 8 subjects | 8 |
| Cohort A HY209 0.05% Gel single dose of HY209 0.05% gel 6 subjects | 6 |
| Cohort A HY209 0.1% Gel single dose of HY209 0.1% gel 6 subjects | 6 |
| Cohort A HY209 0.3% Gel single dose of HY209 0.3% gel 6 subjects | 6 |
| Cohort A HY209 0.5% Gel single dose of HY209 0.5% gel 6 subjects | 6 |
| Cohort B Placebo multiple dose of placebo 6 subjects | 6 |
| Cohort B HY209 0.1% Gel multiple dose of HY209 0.1% gel 6 subjects | 6 |
| Cohort B HY209 0.3% Gel multiple dose of HY209 0.3% gel 6 subjects | 6 |
| Cohort B HY209 0.5% Gel multiple dose of HY209 0.5% gel 6 subjects | 6 |
| Total | 56 |
Baseline characteristics
| Characteristic | Cohort A Placebo | 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 Placebo | Cohort B HY209 0.1% Gel | Cohort B HY209 0.3% Gel | Cohort B HY209 0.5% Gel | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 56 Participants |
| Race and Ethnicity Not Collected | — | — | — | — | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 2 / 8 | 2 / 6 | 1 / 6 | 1 / 6 | 0 / 6 | 1 / 6 | 0 / 6 | 1 / 6 | 1 / 6 |
| serious Total, serious adverse events | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Incidence of Treatment Emergent Adverse Events
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A Placebo | Incidence of Treatment Emergent Adverse Events | 4 Participants |
| Cohort A HY209 0.05% Gel | Incidence of Treatment Emergent Adverse Events | 2 Participants |
| Cohort A HY209 0.1% Gel | Incidence of Treatment Emergent Adverse Events | 2 Participants |
| Cohort A HY209 0.3% Gel | Incidence of Treatment Emergent Adverse Events | 1 Participants |
| Cohort A HY209 0.5% Gel | Incidence of Treatment Emergent Adverse Events | 0 Participants |
| Cohort B Placebo | Incidence of Treatment Emergent Adverse Events | 2 Participants |
| Cohort B HY209 0.1% Gel | Incidence of Treatment Emergent Adverse Events | 2 Participants |
| Cohort B HY209 0.3% Gel | Incidence of Treatment Emergent Adverse Events | 2 Participants |
| Cohort B HY209 0.5% Gel | Incidence of Treatment Emergent Adverse Events | 3 Participants |