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

Conditions

• Moderate to Severe Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• SYX-5219 Oral Capsule — DRUG
  Oral Capsule to be administered at each specific dose level within each cohort

Study Details

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.

Key Dates

Start date

Feb 26, 2025

Status verified

Apr 2026

Primary completion

Aug 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

149 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 Single Ascending Dose (SAD)
  Single dose of SYX-5219 (active or matching placebo) administered on Day 1 for all cohorts and Day 1 of each treatment period for food effect cohorts (in fasted and fed conditions).
• Experimental: Part 2 Multiple Ascending Dose (MAD)
  Multiple doses of SYX-5219 (active or matching placebo) administered once or twice daily for all cohorts.
• Experimental: Part 3 AD Participants Multiple Doses
  Multiple doses of SYX-5219 (active or matching placebo) administered twice daily for multiple dose administration

Primary Outcome Measure

The Proportion of Participants With Treatment-Emergent Adverse Events [ Time Frame: Adverse events are collected from the date of consent until up to 10 days after the dose in Part 1 (Day 11), 14 days after the last dose in Part 2 (Day 28) and up to Day 56 in Part 3. ]

Central Contacts

• Sitryx Therapeutics
  +44 (0)1865 648401
  [email protected]
• Sitryx Therapeutics
  +44 (0) 1865 648401
  [email protected]

Locations (6)

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