NCT07558668 A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis
| NCT ID | NCT07558668 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sitryx Therapeutics Ltd |
| Condition | Moderate to Severe Atopic Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 149 participants |
| Start Date | 2025-02-26 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 149 participants in total. It began in 2025-02-26 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Sitryx Therapeutics
STUDY DIRECTOR
Study Sponsor
Frequently Asked Questions
Who can join the NCT07558668 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Moderate to Severe Atopic Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07558668 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07558668 currently recruiting?
Yes, NCT07558668 is actively recruiting participants. Contact the research team at info@sitryx.com for enrollment information.
Where is the NCT07558668 trial being conducted?
This trial is being conducted at Arkansas City, United States, Fremont, United States, Plainfield, United States, Boardman, United States and 10 additional locations.
Who is sponsoring the NCT07558668 clinical trial?
NCT07558668 is sponsored by Sitryx Therapeutics Ltd. The principal investigator is Sitryx Therapeutics at Study Sponsor. The trial plans to enroll 149 participants.
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