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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
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

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sitryx Clinical Site
Coordinator of this site? Confirm its status
SofiaBulgariaRecruiting
Sitryx Clinical Site
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BerlinGermanyRecruiting
Sitryx Clinical Site
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FrankfurtGermanyRecruiting
Sitryx Clinical Site
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Freiburg im BreisgauGermanyActive, not recruiting
Sitryx Clinical Site
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HerlevDenmarkNot yet recruiting
Sitryx Clinical Site
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ManchesterUnited KingdomRecruiting
Sitryx Clinical Site
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Merthyr TydfilUnited KingdomRecruiting
Sitryx Clinical Site
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DublinIrelandRecruiting
Sitryx Clinical Site
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Arkansas CityUnited StatesRecruiting
Sitryx Clinical Site
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BoardmanUnited StatesRecruiting
Sitryx Clinical Site
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BountifulUnited StatesRecruiting
Sitryx Clinical Site
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FremontUnited StatesRecruiting
Sitryx Clinical Site
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PhiladelphiaUnited StatesRecruiting
Sitryx Clinical Site
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PlainfieldUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.