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.
Trial sites (14)
Facility
City
Region
Status
Sitryx Clinical Site
Arkansas City
Arkansas
Recruiting
Sitryx Clinical Site
Fremont
California
Recruiting
Sitryx Clinical Site
Plainfield
Indiana
Recruiting
Sitryx Clinical Site
Boardman
Ohio
Recruiting
Sitryx Clinical Site
Philadelphia
Pennsylvania
Recruiting
Sitryx Clinical Site
Bountiful
Utah
Recruiting
Sitryx Clinical Site
Sofia
Bulgaria
Recruiting
Sitryx Clinical Site
Herlev
Herlev
Not Yet Recruiting
Sitryx Clinical Site
Berlin
Germany
Recruiting
Sitryx Clinical Site
Frankfurt
Germany
Recruiting
Sitryx Clinical Site
Freiburg im Breisgau
Germany
Active Not Recruiting
Sitryx Clinical Site
Dublin
Ireland
Recruiting
Sitryx Clinical Site
Manchester
United Kingdom
Recruiting
Sitryx Clinical Site
Merthyr Tydfil
United Kingdom
Recruiting
Official registry record
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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