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ZL-1503

Phase 1

Atopic Dermatitis (AD) | Small molecule | Dermatology |Zai Lab Limited|Trials Updated: Aug 7, 2026

ZL-1503 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Nov 2025

ZL-1503 target and mechanism

Molecular targetIL-13 and IL-31R
Target classCytokine Receptors
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

ZL-1503 clinical trials

ZL-1503 · 1 trial · 1 indication

Phase 1 1
NCT07235384A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic DermatitisAtopic Dermatitis (AD)
RECRUITING84 Analytics
PHASE1RECRUITING
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
Atopic Dermatitis (AD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events (AEs)
Up to 48 weeks after last intervention
Number of participants with serious adverse events (SAEs)
Up to 48 weeks after last intervention
Number of participants with clinical laboratory abnormalities
Up to 48 weeks after last intervention
Number of participants with vital sign abnormalities
Up to 48 weeks after last intervention
Number of participants with electrocardiogram (ECG) abnormalities
Up to 48 weeks after last intervention
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ZL-1503: Participants will receive single ascending doses of ZL-1503EXPERIMENTALPart A: Single Ascending Dose (SAD)
ZL-1503: Participants will receive multiple ascending doses of ZL-1503EXPERIMENTALPart B: Multiple Ascending Dose (MAD)

Interventions

NameTypeDescription
ZL-1503DRUGHealthy volunteers will receive ZL-1503.
PlaceboDRUGHealthy volunteers will receive placebo.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites12

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. ...

Countries:AustraliaChinaNew Zealand
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Recent Changes (Last 90 Days)

LOWAug 7, 2026NCT07235384lastUpdatePostDate: changed
LOWAug 7, 2026NCT07235384lastUpdatePostDate: changed

Frequently asked questions about ZL-1503

What is ZL-1503?

ZL-1503 is an investigational small molecule being developed by Zai Lab Limited for atopic dermatitis. It is a Phase 1 asset in dermatology and has not been approved for any use. It is being studied in healthy volunteers and in participants with moderate to severe atopic dermatitis.

What is ZL-1503 used for in atopic dermatitis?

ZL-1503 is being developed for atopic dermatitis, a chronic inflammatory skin condition. The clinical program targets participants with moderate to severe disease. Because ZL-1503 is still in Phase 1 development, it is investigational and is not yet available as a treatment outside of clinical trials.

What does ZL-1503 target?

ZL-1503 targets IL-13 and IL-31R, which are cytokine receptors. IL-13 is a cytokine involved in type 2 inflammation, and IL-31R is the receptor for IL-31, a cytokine linked to itch signaling. By acting on both targets, ZL-1503 is designed as a small molecule with a dual mechanism.

Who is developing ZL-1503?

Zai Lab Limited is developing ZL-1503. Zai Lab is a biopharmaceutical company that trades under the ticker ZLAB. The company is running the ZL-1503 program in dermatology, with atopic dermatitis as the lead indication in its clinical development plan.

What phase is ZL-1503 in?

ZL-1503 is in Phase 1 development. It is investigational and has not been approved by the FDA or any other regulatory agency. The ongoing study is a Phase 1/1b trial, and no trials of ZL-1503 have been completed to date.

What clinical trials is ZL-1503 in?

ZL-1503 is being studied in one active clinical trial, NCT07235384, titled 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. The trial is recruiting, is randomized, double blind and controlled, and plans to enroll 84 participants in Australia, China and New Zealand.