Atopic DermatitisPhase 1ShaperonNCT03492398
A Phase I Study of HY209 Gel in Healthy Male Volunteers for Atopic Dermatitis
A Phase 1 study testing HY209 in people with Atopic Dermatitis, run by Shaperon at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- HY209
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jan 2018to 28 May 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- HY209
- Keywords
- atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HY209Drug
Also called HY209 gel
6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A HY209 0.05% gel | Experimental | single dose of HY209 0.05% gel or single dose of placebo Receives: Drug: HY209 |
| Cohort A HY209 0.1% gel | Experimental | single dose of HY209 0.1% gel or single dose of placebo Receives: Drug: HY209 |
| Cohort A HY209 0.3% gel | Experimental | single dose of HY209 0.3% gel or single dose of placebo Receives: Drug: HY209 |
| Cohort A HY209 0.5% gel | Experimental | single dose of HY209 0.5% gel or single dose of placebo Receives: Drug: HY209 |
| Cohort B HY209 0.1% gel | Experimental | multiple dose of HY209 0.1% gel or multiple dose of placebo Receives: Drug: HY209 |
| Cohort B HY209 0.3% gel | Experimental | multiple dose of HY209 0.3% gel or multiple dose of placebo Receives: Drug: HY209 |
| Cohort B HY209 0.5% gel | Experimental | multiple dose of HY209 0.5% gel or multiple dose of placebo Receives: Drug: HY209 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Measured: upto Day 8(single dosing), upto Day 38(multiple dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start29 Jan 2018
- Primary completion21 Mar 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double blind, placebo-controlled, single and multiple dosing, dose escalation study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaperon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyungsang Yu, Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492398
- Sponsor's protocol ID
- HY209-202
- Acronym
- Shaperon
- Status last verified
- Mar 2020
- First submitted
- 15 Feb 2018
- Last updated
- 29 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03492398
- Acronym / sponsor ID
- Shaperon / HY209-202
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- ShaperonIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 21 Mar 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- A randomized, double blind, placebo-controlled, single and multiple dosing, dose escalation study
| Arm | Type | Receives |
|---|---|---|
| Cohort A HY209 0.05% gel | Experimental | Drug: HY209single dose of HY209 0.05% gel or single dose of placebo |
| Cohort A HY209 0.1% gel | Experimental | Drug: HY209single dose of HY209 0.1% gel or single dose of placebo |
| Cohort A HY209 0.3% gel | Experimental | Drug: HY209single dose of HY209 0.3% gel or single dose of placebo |
| Cohort A HY209 0.5% gel | Experimental | Drug: HY209single dose of HY209 0.5% gel or single dose of placebo |
| Cohort B HY209 0.1% gel | Experimental | Drug: HY209multiple dose of HY209 0.1% gel or multiple dose of placebo |
| Cohort B HY209 0.3% gel | Experimental | Drug: HY209multiple dose of HY209 0.3% gel or multiple dose of placebo |
| Cohort B HY209 0.5% gel | Experimental | Drug: HY209multiple dose of HY209 0.5% gel or multiple dose of placebo |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HY209Also: HY209 gel6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo. | Drug | 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 |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyungsang Yu, Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HY209 in people with Atopic Dermatitis, run by Shaperon at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events (time frame: upto Day 8(single dosing), upto Day 38(multiple dosing)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.