New eczema drug ZL-1503 enters first human safety trial
NCT ID NCT07235384
First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This early-stage trial is testing a new drug called ZL-1503 for safety and how the body processes it. It involves 84 participants: first healthy volunteers, then people with moderate to severe atopic dermatitis (eczema). The study is 'double-blind' and 'placebo-controlled,' meaning some participants get the drug and some get a dummy pill, and neither they nor the doctors know who got what. The main goal is to check for side effects, not yet to see if it works for eczema.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ZL-1503
- What this could lead to
- If this early trial shows ZL-1503 is safe, it could lead to a new treatment option for moderate to severe atopic dermatitis.
- What could go wrong
- This is a very early phase 1 study with only 84 participants, focused on safety. It is too soon to know if ZL-1503 will effectively treat atopic dermatitis or have serious side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Part A: 1. Healthy male and female volunteers, 18-65 years of age 2. Body mass index (BMI) between ≥ 18.5 and \< 32.5 kg/m2 3. Negative pregnancy tests for women of childbearing potential. * Part B: 1. 18-65 years of age; 2. BMI between ≥18.5 and \<40.0 kg/m2 3. Have a diagnosis of AD at least 12 months prior to Day 1; 4. Moderate-to-severe AD at Screening and Baseline visit, defined as: 1. Eczema Area and Severity Index (EASI) score ≥ 16; 2. Affected Body Surface Area (BSA)≥ 10%; 3. vIGA-AD™ score ≥ 3 5. History of an inadequate response to treatment with topical medications 6. Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization. 7. Negative pregnancy tests for women of childbearing potential. Exclusion Criteria: * Part A and B: 1. 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. 2. History of major metabolic, liver, kidney, hematologic or other significant disorders. 3. Abnormal Electrocardiogram (ECG) findings 4. Clinically relevant abnormal lab results, including low blood counts, or abnormal liver and kidney function. 5. History of drug abuse or addiction within 6 months prior to screening 6. Current smoker or use of any nicotine or tobacco containing products within the last 6 months prior to dosing. 7. Donated \>500mL blood within 2 months of dosing. * For Part B only: 1. Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or might interfere with study assessments. 2. Uncontrolled chronic disease that might require bursts of oral corticosteroids. 3. Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
12 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aotearoa Clinical Trials
RECRUITINGAuckland, Auckland, New Zealand
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Hangzhou First People's Hospital
RECRUITINGHangzhou, Zhejiang, China
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Momentum Auckland
RECRUITINGTakapuna, Auckland, New Zealand
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Momentum Hamilton
RECRUITINGHamilton, Hamilton, New Zealand
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Momentum Hutt Valley
RECRUITINGUpper Hutt, Wellington Region, New Zealand
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Momentum Kapiti
RECRUITINGWaikanae, Wellington Region, New Zealand
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Momentum Palmerston North
RECRUITINGPalmerston North, Mananwatu, New Zealand
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Peking University Third Hospital
RECRUITINGBeijing, Beijing Municipality, China
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Shandong Provincial Dermatology Hospital
RECRUITINGJinan, Shandong, China
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Shanghai Skin Disease Hospital
RECRUITINGShanghai, Shanghai Municipality, China
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Skin Health Institute
RECRUITINGCarlton, Victoria, Australia
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Veracity Clinical Research
RECRUITINGWoolloongabba, Queensland, Australia
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