At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- SYX-5219 Oral Capsule (drug)
- How long the study runs
- Study runs about 19 months (dates as stated)
- About the drug or intervention
- SYX-5219 Oral Capsule — drug: Oral Capsule to be administered at each specific dose level within each cohort
- Patient visit burden
- Not specified by the sponsor
In plain English
This 3-part study is testing a medicine called SYX-5219, run by Sitryx Therapeutics Ltd. Parts 1 and 2 involve healthy volunteers aged 18 to 65, and Part 3 involves people with moderate to severe atopic dermatitis (a type of eczema) aged 18 to 65.
Who can take part
- Parts 1 and 2: healthy men and women aged 18 to 65, with a body mass index (BMI) between 18 and 32.
- Parts 1 and 2: women must be unable to have children, or not sexually active.
- Parts 1 and 2: normal results on blood tests, vital signs and heart tracing (ECG).
- Part 3: men and women aged 18 to 65 with a confirmed diagnosis of active atopic dermatitis (eczema) and a BMI of 40 or below.
- Part 3: eczema covering at least 10% of the body surface, at screening and at the start of the study.
- Part 3: an Eczema Area and Severity Index (EASI) score of 16 or more, at screening and at the start.
- Part 3: a Validated Investigator's Global Assessment (vIGA) score of 3 or more (moderate), at screening and at the start.
- Part 3: a Peak Pruritus Numerical Rating Scale (NRS) itch score of 4 or more, at screening and at the start.
Who may not be able to
- Parts 1 and 2: taking any prescription or non-prescription medicines, vitamins, herbal or dietary supplements within 35 days (or 5 half-lives, if longer) before the first dose of the study medicine.
- Part 3: any health problem or abnormal test, vital sign or heart tracing (ECG) result that the study doctor believes would put the person at too much risk.
- Part 3: certain past health problems or treatments listed in the main study exclusion criteria — ask the trial team for details.
What taking part involves
- • Not stated — ask the trial team.
Time commitment: Not stated — ask the trial team about how long the study lasts, how many visits are needed, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 65 Years
- Who
- All
- Number of participants
- 149
- Started
- 2025-02-26
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for moderate to severe atopic dermatitis
- • Phase1 - 149 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)
Who can take part?
- • Ages 18 Years to 65 Years
- • Diagnosed with moderate to severe atopic dermatitis
Where?
- • Manchester - Sitryx Clinical Site
- • Merthyr Tydfil - Sitryx Clinical Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This is a multi-part, adaptive, Phase 1, double-blind, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of SYX-5219 following single ascending doses (SAD), multiple ascending doses (MAD), and selected dosing in participants with atopic dermatitis (AD). Parts 1 and 2 will be conducted at a single site in the UK. Part 3 will be conducted globally at multiple sites. Part 1 (Single Ascending Dose \& Food Effect) Part 1 (SAD) will enrol up to 48 healthy participants in cohorts (3:1, active:placebo). Participants will receive single doses of SYX-5219, with a food effect evaluation including a second dosing period following washout. Part 2 (Multiple Ascending Dose) Part 2 (MAD) will enrol up to 24 healthy participants in cohorts (3:1, active:placebo). Participants will receive multiple doses of SYX-5219 over a defined treatment period. Part 3 (AD Participants) Part 3 will enrol up to 45 participants with AD across multiple global sites. Participants will be randomised (2:1) to receive SYX-5219 or placebo for up to 42 days. Prior exposure to targeted systemic therapy will be limited. Study assessments will include safety and exploratory efficacy evaluations during treatment and follow-up.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 65 Years
- Who can join: All genders
What 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...
- ✓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
Who cannot take part
- ✗Parts 1 \& 2
- ✗Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 35 days or...
- ✗Part 3
- ✗Any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the...
- ✗Has medical history as stated in the main study exclusion criteria.
See the full criteria
Where Is This Study? (2 UK sites)
Sitryx Clinical Site
Manchester M23 9QZ, United Kingdom
Sitryx Clinical Site
Merthyr Tydfil CF48 4DR, United Kingdom
How to Get in Touch
Sitryx Therapeutics
Sponsor contactCONTACT
Sitryx Therapeutics
Sponsor contactCONTACT