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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).

Who can join

Ages 18 to 65 · All sexes · Healthy volunteers welcome

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.

About the study

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.

What is being tested

• SYX-5219 Oral Capsule (drug)

Sponsor: Sitryx Therapeutics Ltd · Participants: 149 · Started: Feb 26, 2025

Contact the study team

• Sitryx Therapeutics · Phone: +44 (0)1865 648401
• Sitryx Therapeutics · Phone: +44 (0) 1865 648401

Official record on ClinicalTrials.gov — NCT07558668

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.