A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- The Proportion of Participants With Treatment-Emergent Adverse Events — 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.
The number of participants who reported a treatment-emergent adverse event (TEAE) will be summarised.
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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