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Study of SYX-5219 for Atopic Dermatitis

This study is testing a new oral capsule called SYX-5219. It's a "first-in-human" study, meaning it's one of the first times this drug is being given to people. The main goals are to see how safe SYX-5219 is, how well your body tolerates it, and how much of the drug gets into your blood and urine. The study will first involve healthy volunteers, and then people with moderate to severe atopic dermatitis (eczema). To join, you need to be between 18 and 65 years old. The study will measure any side effects you might experience to understand the drug's safety. The current recruitment status is unclear.

Study design
This is a multi-part, adaptive Phase 1 study that is double-blinded (meaning neither you nor your doctor will know if you're getting the drug or a placebo). It plans to enroll up to 149 participants.
What's involved
Participants will receive SYX-5219 oral capsules at specific dose levels. The study involves single doses, multiple doses over a period, and a food effect evaluation.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be collected for up to 10 days after the dose in Part 1, 14 days after the last dose in Part 2, and up to 56 days in Part 3.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07558668

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

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Sitryx Therapeutics Ltd
~149 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:SYX-5219 Oral Capsule

At a glance

Recruiting sites
12 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The Proportion of Participants With Treatment-Emergent Adverse Events
Measured over Adverse events are collected from the date of consent until up to 10 days after the dose in Part 1 (Day 11), 14 days after the last dose in Part 2 (Day 28) and up to Day 56 in Part 3.

Conditions

Moderate to Severe Atopic Dermatitis

Explore related trials

Atopic Dermatitis

Where it's being run

14 sites across 11 states
Germany3
United Kingdom2
Arkansas1
California1
Indiana1
Ohio1
Pennsylvania1
Utah1

Study leadership

  • Sitryx Therapeutics · STUDY_DIRECTOR · Study Sponsor

Who to contact

Sitryx Therapeutics
[email protected]
+44 (0)1865 648401
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

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.

What this trial measures

  • The Proportion of Participants With Treatment-Emergent Adverse EventsAdverse events are collected from the date of consent until up to 10 days after the dose in Part 1 (Day 11), 14 days after the last dose in Part 2 (Day 28) and up to Day 56 in Part 3.

    The number of participants who reported a treatment-emergent adverse event (TEAE) will be summarised.