New pill for eczema enters first human tests
NCT ID NCT07558668
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tests a new oral drug called SYX-5219 in healthy volunteers and people with moderate to severe atopic dermatitis (eczema). The main goal is to check safety and how the drug moves through the body. About 149 participants will take single or multiple doses over 42 days. It is too early to know if the drug works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SYX-5219 oral capsule
- What this could lead to
- If successful, this could lead to a new oral treatment option for moderate to severe atopic dermatitis, potentially easing symptoms like itching and inflammation.
- What could go wrong
- This is a very early Phase 1 trial focused on safety, not yet on effectiveness. The drug may fail to show benefit or cause side effects. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 149 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Parts 1 \& 2 * Healthy male and female participant, between ≥ 18 to ≤ 65 years of age, inclusive, with a BMI of body mass index (BMI) of 18-32 kg/m2. * Female participant of non-childbearing potential or female of childbearing potential that is sexually abstinent. * No clinically significant abnormalities in laboratory, vital signs or ECG measurements. Part 3 * Male and female participants with clinically confirmed diagnosis of active AD, between ≥ 18 to ≤ 65 years of age, inclusive, with a BMI of body mass index (BMI) of ≤40 kg/m2. * Meet minimum AD entry criteria; * AD covering ≥10% of the body surface area (BSA) at screening and baseline. * Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline. * Validated Investigator's Global Assessment (vIGA) score of ≥ 3 (moderate) at screening and baseline. * Peak Pruritus NRS score of ≥ 4 at screening and baseline. Exclusion Criteria: Parts 1 \& 2 • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 35 days or 5 half-lives (whichever is longer) prior to the first dose of IMP. Part 3 * Any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the Investigator, put the participant at undue risk. * Has medical history as stated in the main study exclusion criteria. * Received treatment(s) as stated in the main study exclusion criteria.
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Get notified about this study
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
13 sites in 6 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
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Contact
Email: •••••@•••••
Locations
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Sitryx Clinical Site
RECRUITINGArkansas City, Arkansas, 72117, United States
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Sitryx Clinical Site
RECRUITINGFremont, California, 94538, United States
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Sitryx Clinical Site
RECRUITINGPlainfield, Indiana, 46168, United States
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Sitryx Clinical Site
RECRUITINGBoardman, Ohio, 44512, United States
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Sitryx Clinical Site
RECRUITINGPhiladelphia, Pennsylvania, 19103, United States
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Sitryx Clinical Site
RECRUITINGBountiful, Utah, 84010, United States
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Sitryx Clinical Site
RECRUITINGSofia, 1404, Bulgaria
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Sitryx Clinical Site
NOT_YET_RECRUITINGHerlev, Herlev, 2730, Denmark
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Sitryx Clinical Site
RECRUITINGBerlin, 10117, Germany
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Sitryx Clinical Site
RECRUITINGFrankfurt, 60596, Germany
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Sitryx Clinical Site
ACTIVE_NOT_RECRUITINGFreiburg im Breisgau, 79106, Germany
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Sitryx Clinical Site
RECRUITINGDublin, D08 NHY1, Ireland
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Sitryx Clinical Site
RECRUITINGManchester, M23 9QZ, United Kingdom
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Sitryx Clinical Site
RECRUITINGMerthyr Tydfil, CF48 4DR, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new injection calm severe eczema?
- Can a new injection quiet the itch of severe eczema?
- Can a new pill tame tough eczema? a large trial aims to find out
- New shot could tame tough eczema by calming overactive immune cells
- New drug aims to calm severe eczema without steroids
- New drug shows promise for severe eczema in toddlers