A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Vo… (NCT07235384) | Clinical Trial Compass
RecruitingPhase 1
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
Australia, China, New Zealand84 participantsStarted 2025-12-01
Plain-language 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)
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 18-65 years of age;
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events (AEs)
Timeframe: Up to 48 weeks after last intervention
2
Number of participants with serious adverse events (SAEs)
Timeframe: Up to 48 weeks after last intervention
3
Number of participants with clinical laboratory abnormalities
Timeframe: Up to 48 weeks after last intervention
4
Number of participants with vital sign abnormalities
Timeframe: Up to 48 weeks after last intervention
5
Number of participants with electrocardiogram (ECG) abnormalities
. 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
. 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.
. Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or might interfere with study assessments.