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Taking people in GermanyPhase 1

First study of the oral drug SYX-5219 in healthy people and atopic dermatitis

Tests the safety of SYX-5219 in healthy adults and adults with atopic dermatitis.

Plain-language title generated from the registry record
Registry title: A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis

Key facts

Where
Berlin, Frankfurt, and Freiburg im Breisgau, GermanySee the 3 sites
Phase
Phase 1

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for healthy adults (Parts 1 and 2) and adults with active moderate to severe atopic dermatitis (Part 3) to test the safety of the study drug SYX-5219.

Age
18 to 65 years
Sex
Men and women can join
Disease stage
Part 3: active atopic dermatitis confirmed by a doctor, covering at least 10% of the body surface, with EASI score of 16 or more, vIGA score of 3 (moderate) or more, and Peak Pruritus NRS score of 4 or more.
Earlier treatment
Parts 1 and 2: no prescription or non-prescription drugs, vitamins, herbal or dietary supplements within 35 days or 5 half-lives (whichever is longer) before the first dose. Part 3: certain earlier treatments listed in the main study exclusion criteria are not allowed.

Main reasons for not taking part

  • Any medical condition or abnormal lab, ECG or vital sign result that the investigator thinks would put the person at undue risk
  • Medical history named in the main study exclusion criteria (Part 3)
  • Treatments named in the main study exclusion criteria (Part 3)
  • Use of prescription or non-prescription drugs, vitamins or supplements within 35 days or 5 half-lives before the first dose (Parts 1 and 2)
  • Women who could become pregnant and are not sexually abstinent (Parts 1 and 2)

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Source: NCT07558668, who can take part

Where in Germany

  • BerlinHospital not named in the registryTaking people
  • FrankfurtHospital not named in the registryTaking people
  • Freiburg im BreisgauHospital not named in the registryNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Sitryx Therapeutics Ltd
Trial code
NCT07558668
Record updated
30 April 2026
Original description
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).Read full original descriptionShow less

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).

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.

Inclusion: 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: 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; 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; Parts 1 \& 2; Has medical history as stated in the main study exclusion criteria.

ClinicalTrials.gov NCT07558668