Atopic Dermatitis (AD)Phase 1NCT07235384
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 study testing ZL-1503 in people with Atopic Dermatitis (AD), run by Zai Lab (Shanghai) Co., Ltd. at 12 sites in 3 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- ZL-1503
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 1 Dec 2025to 28 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
12 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 3 countries
New Zealand6 sites, 6 recruiting
- Recruiting
Aotearoa Clinical Trials
Auckland, Auckland
- Recruiting
Momentum Hamilton
Hamilton, Hamilton
- Recruiting
Momentum Palmerston North
Palmerston North, Mananwatu
- Recruiting
Momentum Auckland
Takapuna, Auckland
- Recruiting
Momentum Hutt Valley
Upper Hutt, Wellington Region
- Recruiting
Momentum Kapiti
Waikanae, Wellington Region
China4 sites, 4 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang
- Recruiting
Shandong Provincial Dermatology Hospital
Jinan, Shandong
- Recruiting
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality
Australia2 sites, 2 recruiting
- Recruiting
Skin Health Institute
Carlton, Victoria
- Recruiting
Veracity Clinical Research
Woolloongabba, Queensland
About this study
Official title: 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)
Read the detailed description
The study consists of two parts:
- Part A: single ascending dose in healthy volunteers
- Part B: multiple ascending doses in adult participants with moderate to severe AD
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- ZL-1503, Placebo
- Keywords
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZL-1503Drug
Healthy volunteers will receive ZL-1503.
PlaceboDrug
Healthy volunteers will receive placebo.
ZL-1503Drug
Participants with moderate to severe atopic dermatitis will receive ZL-1503.
PlaceboDrug
Participants with moderate to severe atopic dermatitis will receive placebo.
| Study group | Role | What they receive |
|---|---|---|
| ZL-1503: Participants will receive single ascending doses of ZL-1503 | Experimental | Part A: Single Ascending Dose (SAD) Receives: Drug: ZL-1503; Drug: Placebo |
| ZL-1503: Participants will receive multiple ascending doses of ZL-1503 | Experimental | Part B: Multiple Ascending Dose (MAD) Receives: Drug: ZL-1503; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Up to 48 weeks after last intervention
Number of participants with serious adverse events (SAEs)
Measured: Up to 48 weeks after last intervention
Number of participants with clinical laboratory abnormalities
Measured: Up to 48 weeks after last intervention
Number of participants with vital sign abnormalities
Measured: Up to 48 weeks after last intervention
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 48 weeks after last intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Dec 2025
- Primary completion28 Dec 2027 (estimated)
- Study completion28 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235384
- Sponsor's protocol ID
- ZL-1503-001
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07235384
- Acronym / sponsor ID
- ZL-1503-001
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 28 Dec 2027 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
The study consists of two parts:
- Part A: single ascending dose in healthy volunteers
- Part B: multiple ascending doses in adult participants with moderate to severe AD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZL-1503: Participants will receive single ascending doses of ZL-1503 | Experimental | Drug: ZL-1503, Drug: PlaceboPart A: Single Ascending Dose (SAD) |
| ZL-1503: Participants will receive multiple ascending doses of ZL-1503 | Experimental | Drug: ZL-1503, Drug: PlaceboPart B: Multiple Ascending Dose (MAD) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Part A:
- Part B:
Key exclusion criteria (12 listed)
- Part A and B:
- For Part B only:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZL-1503Healthy volunteers will receive ZL-1503. | Drug | ZL-1503: Participants will receive single ascending doses of ZL-1503 |
| PlaceboHealthy volunteers will receive placebo. | Drug | ZL-1503: Participants will receive single ascending doses of ZL-1503 |
| ZL-1503Participants with moderate to severe atopic dermatitis will receive ZL-1503. | Drug | ZL-1503: Participants will receive multiple ascending doses of ZL-1503 |
| PlaceboParticipants with moderate to severe atopic dermatitis will receive placebo. | Drug | ZL-1503: Participants will receive multiple ascending doses of ZL-1503 |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 48 weeks after last intervention
Number of participants with serious adverse events (SAEs)
Time frame: Up to 48 weeks after last intervention
Number of participants with clinical laboratory abnormalities
Time frame: Up to 48 weeks after last intervention
Number of participants with vital sign abnormalities
Time frame: Up to 48 weeks after last intervention
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 48 weeks after last intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZL-1503 in people with Atopic Dermatitis (AD), run by Zai Lab (Shanghai) Co., Ltd. at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in New Zealand, China, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZaiLab Medical Director (+86 021-61632588, ZaiLab_1503-001_StudyTeam@zailaboratory.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: Up to 48 weeks after last intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.