Actively Recruiting
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
Led by Zai Lab (Shanghai) Co., Ltd. · Updated on 2025-12-19
84
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Part A: Healthy male and female volunteers aged 18 to 65 years
- Body mass index (BMI) between 18.5 and less than 32.5 kg/m2 for Part A
- Negative pregnancy tests for women of childbearing potential in Part A
- Part B: Adults aged 18 to 65 years
- BMI between 18.5 and less than 40.0 kg/m2 for Part B
- Diagnosis of atopic dermatitis for at least 12 months before Day 1
- Moderate to severe atopic dermatitis at screening and baseline, defined by EASI score of at least 16, affected body surface area of at least 10%, and vIGA-AD score of at least 3
- History of inadequate response to topical medications
- Average peak pruritus numeric rating scale score of 4 or higher in the 7 days before randomization
- Negative pregnancy tests for women of childbearing potential in Part B
You will not qualify if you...
- Significant health problems such as positive tests for HIV, hepatitis C, hepatitis B surface antigen, active tuberculosis, immunodeficiencies, or autoimmune diseases
- History of major metabolic, liver, kidney, hematologic, or other significant disorders
- Abnormal electrocardiogram (ECG) findings
- Clinically relevant abnormal laboratory results including low blood counts or abnormal liver and kidney function
- History of drug abuse or addiction within 6 months before screening
- Current smoker or use of nicotine or tobacco products within 6 months before dosing
- Donated more than 500 mL of blood within 2 months of dosing
- For Part B only: presence of skin conditions or comorbidities that may interfere with atopic dermatitis diagnosis or study assessments
- Uncontrolled chronic diseases requiring oral corticosteroid bursts
- Any other medical, psychiatric, or social reason judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ZaiLab Site 18001
Auckland, Auckland, New Zealand
Actively Recruiting
Research Team
Z
ZaiLab Medical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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