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

NCT07558668 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2026-04-30

No results posted yet for this 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.

Conditions

  • Moderate to Severe Atopic Dermatitis

Interventions

DRUG

SYX-5219 Oral Capsule

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

Sponsors & Collaborators

  • Sitryx Therapeutics Ltd

    lead INDUSTRY

Principal Investigators

  • Sitryx Therapeutics · Study Sponsor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-26
Primary Completion
2026-08-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Denmark
  • Germany
  • Ireland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07558668 on ClinicalTrials.gov