Actively Recruiting
A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis
Led by Sitryx Therapeutics Ltd · Updated on 2026-04-30
149
Participants Needed
14
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 males and females aged 18 to 65 years with a BMI of 18-32 kg/m2 for Parts 1 and 2
- Females must be of non-childbearing potential or sexually abstinent if of childbearing potential
- No clinically significant abnormalities in lab tests, vital signs, or ECG for Parts 1 and 2
- Males and females aged 18 to 65 years with confirmed active atopic dermatitis for Part 3
- Body mass index (BMI) of 40 kg/m2 or less for Part 3
- 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 score of 3 (moderate) or higher at screening and baseline
- Peak Pruritus Numeric Rating Scale score of 4 or higher at screening and baseline
You will not qualify if you...
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 35 days or 5 half-lives prior to first dose for Parts 1 and 2
- Any clinically significant medical condition or abnormal lab, ECG, or vital signs that pose undue risk for Part 3
- Medical history or prior treatments as stated in the main study exclusion criteria for Part 3
AI-Screening
AI-Powered Screening
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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
CONTACT
S
Sitryx Therapeutics
CONTACT
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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