NCT07558668RecruitingPhase 1
A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis
A Multi-part, FiH Study in Healthy Participants and Participants With Atopic Dermatitis (AD) to Assess the Safety, Tolerability, Pharmacokinetics (PK) of Single & Multiple Ascending Doses and Selected Dose of SYX-5219 (AD Participants).
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the study drug, SYX-5219, in a multi-part First-in-Human (FiH) study to be conducted in healthy volunteers and participants with Atopic Dermatitis (AD). The objectives of this study are to determine the safety, tolerability and levels of SYX-5219 in the blood and urine when SYX-5219 is given in each part of the study (SAD, MAD, Food Effect and Participants with AD). The study will be split into up to 3 parts as follows: * Part 1 - Single Ascending Dose (SAD) and Food Effect in healthy volunteers * Part 2 - Multiple Ascending Dose (MAD) in healthy volunteers * Part 3 - Multiple Dose in Participants with AD - enrolling up to 45 males and females with a confirmed diagnosis of AD of at least 6 months, evaluating multiple dose administrations of SYX-5219 or placebo daily over a period of 42 days.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 149 (estimated)
- First submitted
- 22 Apr 2026
- Start date
- 26 Feb 2025
- Primary completion date
- 30 Aug 2026
- Lead sponsor
- Sitryx Therapeutics Ltd
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07558668
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 149
- From 26 Feb 2025 to the primary completion date, 30 Aug 2026
- 14 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Received treatment(s) as stated in the main study exclusion criteria.
Lab values
- 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.
Other
- Parts 1 \& 2
- Has medical history as stated in the main study exclusion criteria.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sitryx Clinical Site Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Sitryx Clinical Site Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Sitryx Clinical Site Coordinator of this site? Confirm its status | Frankfurt | Germany | Recruiting |
| Sitryx Clinical Site Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Active, not recruiting |
| Sitryx Clinical Site Coordinator of this site? Confirm its status | Herlev | Denmark | Not yet recruiting |
| Sitryx Clinical Site Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Sitryx Clinical Site Coordinator of this site? Confirm its status | Merthyr Tydfil | United Kingdom | Recruiting |
| Sitryx Clinical Site Coordinator of this site? Confirm its status | Dublin | Ireland | Recruiting |
| Sitryx Clinical Site Coordinator of this site? Confirm its status | Arkansas City | United States | Recruiting |
| Sitryx Clinical Site Coordinator of this site? Confirm its status | Boardman | United States | Recruiting |
| Sitryx Clinical Site Coordinator of this site? Confirm its status | Bountiful | United States | Recruiting |
| Sitryx Clinical Site Coordinator of this site? Confirm its status | Fremont | United States | Recruiting |
| Sitryx Clinical Site Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Sitryx Clinical Site Coordinator of this site? Confirm its status | Plainfield | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.