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RECRUITING
NCT07558668
PHASE1

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

Sponsor: Sitryx Therapeutics Ltd

View on ClinicalTrials.gov

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.

Official title: 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).

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

149

Start Date

2025-02-26

Completion Date

2026-09-30

Last Updated

2026-04-30

Healthy Volunteers

Yes

Interventions

DRUG

SYX-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