Tests ZL-1503 safety in healthy people and adults with atopic dermatitis
Tests the drug ZL-1503 in healthy adults and adults with moderate to severe atopic dermatitis.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Carlton and Woolloongabba, AustraliaSee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adults (Part A) and adults with moderate to severe atopic dermatitis (Part B) to test the safety of ZL-1503.
- Age
- 18 to 65 years
- Sex
- Men and women
- Disease stage
- Part B: atopic dermatitis for at least 12 months, moderate to severe (EASI score ≥ 16, affected body surface area ≥ 10%, vIGA-AD score ≥ 3, average peak itch score ≥4 in the 7 days before randomization). Part A: healthy volunteers.
- Earlier treatment
- Part B: inadequate response to treatment with topical medications.
Main reasons for not taking part
- Positive tests for HIV, hepatitis C or hepatitis B, active tuberculosis, immune deficiency or autoimmune disease
- Major metabolic, liver, kidney or blood disorders
- Abnormal heart tracing (ECG) or clinically relevant abnormal lab results
- Drug abuse or addiction within 6 months before screening
- Part B: other skin conditions that could confuse the diagnosis, or uncontrolled chronic disease that may need bursts of oral corticosteroids
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07235384, who can take part
Where in Australia
- Skin Health InstituteCarlton, AustraliaContact: ZaiLab Medical DirectorTaking people
- Veracity Clinical ResearchWoolloongabba, AustraliaContact: ZaiLab Medical DirectorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Zai Lab (Shanghai) Co., Ltd.
- Trial code
- NCT07235384
- Record updated
- 4 November 2026
- Original description
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)Read full original descriptionShow less
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)
Inclusion: 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: 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; Smoke > 10 cigarettes or the equivalent (including electronic cigarettes) per day; 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, in the investigator's judgment, make the participant unsuitable for study participation; History of drug abuse or addiction within 6 months prior to screening; Donated >500mL blood within 2 months of dosing.