SYX-5219 Oral Capsule: Oral Capsule to be administered at each specific dose level within each cohort
Study 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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
The Proportion of Participants With Treatment-Emergent Adverse Events — 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. The number of participants who reported a treatment-emergent adverse event (TEAE) will be summarised.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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