A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis
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)
Zai Lab (Shanghai) Co., Ltd.
84 participants
Dec 1, 2025
INTERVENTIONAL
Conditions
Summary
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)
Eligibility
Inclusion Criteria15
- 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.
Exclusion Criteria12
- Part A and B:
- Significant health issues, such as positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), active tuberculosis, immunodeficiencies or autoimmune diseases.
- History of major metabolic, liver, kidney, hematologic or other significant disorders.
- Abnormal Electrocardiogram (ECG) findings
- Clinically relevant abnormal lab results, including low blood counts, or abnormal liver and kidney function.
- History of drug abuse or addiction within 6 months prior to screening
- Current smoker or use of any nicotine or tobacco containing products within the last 6 months prior to dosing.
- Donated >500mL blood within 2 months of dosing.
- For Part B only:
- Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or might interfere with study assessments.
- Uncontrolled chronic disease that might require bursts of oral corticosteroids.
- Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
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Interventions
Healthy volunteers will receive ZL-1503.
Healthy volunteers will receive placebo.
Participants with moderate to severe atopic dermatitis will receive ZL-1503.
Participants with moderate to severe atopic dermatitis will receive placebo.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07235384