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

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.

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.