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Clinical Trials in Ireland / NCT07558668
Recruiting Phase 1

A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis

NCT07558668 · tracked via the Priya Life Science Ireland tracker
Sponsor
Sitryx Therapeutics Ltd
Phase
Phase 1
Started
2025-02-26
Last updated
2026-04-30

Condition(s) studied

Moderate to Severe Atopic Dermatitis

Investigational drug(s) / intervention(s)

SYX-5219 Oral Capsule

SYX-5219 Oral Capsule: Oral Capsule to be administered at each specific dose level within each cohort

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: 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 Criteria: Parts 1 \& 2 • 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 * 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. * Has medical history as stated in the main study exclusion criteria. * Received treatment(s) as stated in the main study exclusion criteria.

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Sitryx Clinical Site Arkansas City Arkansas Recruiting
Sitryx Clinical Site Fremont California Recruiting
Sitryx Clinical Site Plainfield Indiana Recruiting
Sitryx Clinical Site Boardman Ohio Recruiting
Sitryx Clinical Site Philadelphia Pennsylvania Recruiting
Sitryx Clinical Site Bountiful Utah Recruiting
Sitryx Clinical Site Sofia Bulgaria Recruiting
Sitryx Clinical Site Herlev Herlev Not Yet Recruiting
Sitryx Clinical Site Berlin Germany Recruiting
Sitryx Clinical Site Frankfurt Germany Recruiting
Sitryx Clinical Site Freiburg im Breisgau Germany Active Not Recruiting
Sitryx Clinical Site Dublin Ireland Recruiting
Sitryx Clinical Site Manchester United Kingdom Recruiting
Sitryx Clinical Site Merthyr Tydfil United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07558668 on ClinicalTrials.gov ↗ ← All trials in Ireland