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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Atopic Dermatitis (AD)

In brief

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)

Key facts

Study ID

NCT07235384

Run by

Zai Lab (Shanghai) Co., Ltd.

People needed

84

Starts

2025-12-01

Expected to finish

2027-12-28

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Veracity Clinical Research — Woolloongabba, Queensland, Australia (enrolling)
• Skin Health Institute — Carlton, Victoria, Australia (enrolling)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (enrolling)
• Shandong Provincial Dermatology Hospital — Jinan, Shandong, China (enrolling)
• Shanghai Skin Disease Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (enrolling)
• Aotearoa Clinical Trials — Auckland, Auckland, New Zealand (enrolling)
• Momentum Auckland — Takapuna, Auckland, New Zealand (enrolling)
• Momentum Hamilton — Hamilton, Hamilton, New Zealand (enrolling)
• Momentum Palmerston North — Palmerston North, Mananwatu, New Zealand (enrolling)
• Momentum Hutt Valley — Upper Hutt, Wellington Region, New Zealand (enrolling)
• Momentum Kapiti — Waikanae, Wellington Region, New Zealand (enrolling)

Full record on ClinicalTrials.gov

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