AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 1Ages 18 Years - 65 YearsAllZai Lab (Shanghai) Co., Ltd.
💬

In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
💊

What it tests

  • ZL-1503
  • Placebo
  • ZL-1503
  • Placebo
📍

Where

12 sites
Veracity Clinical Research
Woolloongabba, Australia
Skin Health Institute
Carlton, Australia
Peking University Third Hospital
Beijing, China
Shandong Provincial Dermatology Hospital
Jinan, China
Shanghai Skin Disease Hospital
Shanghai, China
Hangzhou First People's Hospital
Hangzhou, China
Aotearoa Clinical Trials
Auckland, New Zealand
Momentum Auckland
Takapuna, New Zealand

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy