Recruiting
Phase 1

SYX-5219

Sponsor:

Sitryx Therapeutics Ltd

Code:

NCT07558668

Conditions

Moderate to Severe Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

SYX-5219 Oral Capsule

Study Details

Brief 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.

Conditions

Moderate to Severe Atopic Dermatitis

Study ID

NCT07558668

Start date

Feb 26, 2025

Status verified date

Apr, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Aug 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

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.

Study Design

Enrollment

149 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 Single Ascending Dose (SAD)

Single dose of SYX-5219 (active or matching placebo) administered on Day 1 for all cohorts and Day 1 of each treatment period for food effect cohorts (in fasted and fed conditions).

experimental: Part 2 Multiple Ascending Dose (MAD)

Multiple doses of SYX-5219 (active or matching placebo) administered once or twice daily for all cohorts.

experimental: Part 3 AD Participants Multiple Doses

Multiple doses of SYX-5219 (active or matching placebo) administered twice daily for multiple dose administration

Interventions

SYX-5219 Oral Capsule

Oral Capsule to be administered at each specific dose level within each cohort

Primary outcome measure

  • The Proportion of Participants With Treatment-Emergent Adverse Events [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Sitryx Therapeutics

+44 (0)1865 648401info@sitryx.com

Sitryx Therapeutics

+44 (0) 1865 648401info@sitryx.com

Locations

Sitryx Clinical Site

Recruiting

Arkansas City, Arkansas, United States, 72117

Sitryx Clinical Site

Recruiting

Fremont, California, United States, 94538

Sitryx Clinical Site

Recruiting

Plainfield, Indiana, United States, 46168

Sitryx Clinical Site

Recruiting

Boardman, Ohio, United States, 44512

Sitryx Clinical Site

Recruiting

Philadelphia, Pennsylvania, United States, 19103

Sitryx Clinical Site

Recruiting

Bountiful, Utah, United States, 84010

More Information

Sponsor

Sitryx Therapeutics Ltd

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sitryx Therapeutics Ltd on 2026-04-30.