A Phase 1/1b Randomized, Double Blind, Placebo-controlled, Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis (AD)
This is a phase 1/1b randomized, double blind, placebo-controlled, single dose escalation (SAD) and multiple dose escalation (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ZL-1503 in healthy volunteers and participants with moderate to severe atopic dermatitis (AD)
• Part A:
‣ Healthy male and female volunteers, 18-65 years of age
⁃ Body mass index (BMI) between ≥ 18.5 and \< 32.5 kg/m2
⁃ Negative pregnancy tests for women of childbearing potential.
• Part B:
‣ 18-65 years of age;
⁃ BMI between ≥18.5 and \<40.0 kg/m2
⁃ Have a diagnosis of AD at least 12 months prior to Day 1;
⁃ Moderate-to-severe AD at Screening and Baseline visit, defined as:
• Eczema Area and Severity Index (EASI) score ≥ 16;
∙ Affected Body Surface Area (BSA)≥ 10%;
∙ vIGA-AD™ score ≥ 3
⁃ History of an inadequate response to treatment with topical medications
⁃ Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.
⁃ Negative pregnancy tests for women of childbearing potential.