RecruitingPhase 1NCT07558668

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

A Multi-part, FiH Study in Healthy Participants and Participants With Atopic Dermatitis (AD) to Assess the Safety, Tolerability, Pharmacokinetics (PK) of Single & Multiple Ascending Doses and Selected Dose of SYX-5219 (AD Participants).


Sponsor

Sitryx Therapeutics Ltd

Enrollment

149 participants

Start Date

Feb 26, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called SYX-5219 Oral Capsule for people with moderate-to-severe atopic dermatitis. The study is currently recruiting participants at 14 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSYX-5219 Oral Capsule

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


Locations(14)

Sitryx Clinical Site

Arkansas City, Arkansas, United States

Sitryx Clinical Site

Fremont, California, United States

Sitryx Clinical Site

Plainfield, Indiana, United States

Sitryx Clinical Site

Boardman, Ohio, United States

Sitryx Clinical Site

Philadelphia, Pennsylvania, United States

Sitryx Clinical Site

Bountiful, Utah, United States

Sitryx Clinical Site

Sofia, Bulgaria

Sitryx Clinical Site

Herlev, Herlev, Denmark

Sitryx Clinical Site

Berlin, Germany

Sitryx Clinical Site

Frankfurt, Germany

Sitryx Clinical Site

Freiburg im Breisgau, Germany

Sitryx Clinical Site

Dublin, Ireland

Sitryx Clinical Site

Manchester, United Kingdom

Sitryx Clinical Site

Merthyr Tydfil, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07558668


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