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ZL-1503

Phase 1

Atopic Dermatitis (AD) | Small molecule | Immunology |Zai Lab Limited|Last Updated: Dec 19, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment84
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07235384A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic DermatitisPHASE1 RECRUITING 84Dec 1, 2025Dec 28, 2027Dec 19, 20251 New Zealand
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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 — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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:New Zealand
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07235384primaryCompletionDate: changed
LOWMay 24, 2026NCT07235384studyFirstPostDate: changed