Actively Recruiting
A Multi-part, First-in-Human Study of SYX-5219 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis to Assess Safety, Tolerability, and Pharmacokinetics
Led by Sitryx Therapeutics Ltd · Updated on 2026-04-30
149
Participants Needed
14
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SYX-5219 in a multi-part, first-in-human Phase 1 study involving healthy volunteers and people with moderate to severe atopic dermatitis (AD). The study aims to determine the safety, tolerability, and levels of SYX-5219 in blood and urine when given in different dosing schedules. This includes single ascending doses, multiple ascending doses, and multiple dose administrations in participants with AD. The study has three parts: Part 1 involves single ascending doses and a food effect evaluation in healthy volunteers, with doses given once on Day 1 and again after a washout period. Part 2 involves multiple ascending doses given once or twice daily to healthy volunteers over a defined period. Part 3 enrolls participants with AD who receive SYX-5219 or placebo twice daily for up to 42 days. Each part includes randomization and placebo control to compare effects. Participants will undergo safety and exploratory efficacy assessments during and after treatment, including monitoring adverse events up to 10 days after dosing in Part 1, 14 days after the last dose in Part 2, and up to Day 56 in Part 3. Blood and urine samples are collected at multiple timepoints to measure SYX-5219 levels. The study includes follow-up visits to monitor participant health and drug effects for several weeks after treatment ends.
CONDITIONS
Brief Title
A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male and female participants aged 18 to 65 years with BMI between 18 and 32 kg/m2 for Parts 1 and 2
- Female participants must be of non-childbearing potential or sexually abstinent for Parts 1 and 2
- No clinically significant abnormalities in laboratory tests, vital signs, or ECG for Parts 1 and 2
- Male and female participants aged 18 to 65 years with clinically confirmed active atopic dermatitis for Part 3
- Participants with atopic dermatitis must have BMI of 40 kg/m2 or less
- Atopic dermatitis covering at least 10% of body surface area at screening and baseline
- Eczema Area and Severity Index (EASI) score of 16 or higher at screening and baseline
- Validated Investigator's Global Assessment (vIGA) score of 3 or higher (moderate) at screening and baseline
- Peak Pruritus Numeric Rating Scale (NRS) score of 4 or higher at screening and baseline
You will not qualify if you...
- Use of prescription or non-prescription drugs, including vitamins and supplements, within 35 days or 5 half-lives before first dose for Parts 1 and 2
- Any clinically significant medical condition or abnormal physical, laboratory, ECG, or vital signs that may increase risk for Part 3
- Medical history or prior treatments that exclude participation as stated in the main study exclusion criteria for Part 3
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 42 days depending on the study part
Participants receive SYX-5219 or placebo in one of three parts: single ascending dose, multiple ascending doses, or multiple doses for atopic dermatitis, to assess safety and pharmacokinetics.
Multiple visits during dosing periods depending on cohort and part assignment
Duration - Up to 56 days depending on the study part
Participants are monitored for safety and adverse events after the last dose of study drug.
1 to 2 visits after treatment completion
Trial Site Locations
Total: 14 locations
1
Sitryx Clinical Site
Arkansas City, Arkansas, United States, 72117
Actively Recruiting
2
Sitryx Clinical Site
Fremont, California, United States, 94538
Actively Recruiting
3
Sitryx Clinical Site
Plainfield, Indiana, United States, 46168
Actively Recruiting
4
Sitryx Clinical Site
Boardman, Ohio, United States, 44512
Actively Recruiting
5
Sitryx Clinical Site
Philadelphia, Pennsylvania, United States, 19103
Actively Recruiting
6
Sitryx Clinical Site
Bountiful, Utah, United States, 84010
Actively Recruiting
7
Sitryx Clinical Site
Sofia, Bulgaria, 1404
Actively Recruiting
8
Sitryx Clinical Site
Herlev, Herlev, Denmark, 2730
Not Yet Recruiting
9
Sitryx Clinical Site
Berlin, Germany, 10117
Actively Recruiting
10
Sitryx Clinical Site
Frankfurt, Germany, 60596
Actively Recruiting
11
Sitryx Clinical Site
Freiburg im Breisgau, Germany, 79106
Active, Not Recruiting
12
Sitryx Clinical Site
Dublin, Ireland, D08 NHY1
Actively Recruiting
13
Sitryx Clinical Site
Manchester, United Kingdom, M23 9QZ
Actively Recruiting
14
Sitryx Clinical Site
Merthyr Tydfil, United Kingdom, CF48 4DR
Actively Recruiting
Research Team
S
Sitryx Therapeutics
S
Sitryx Therapeutics
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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