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
- Herlev, DenmarkSee the site
- Phase
- Phase 1
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 Denmark
- HerlevHerlev, DenmarkNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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.