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Tests treatment safety and results for Atopic Dermatitis (AD)
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
ClinicalTrials.gov ID: NCT07235384
What this study is testing
What is ZL-1503?
ZL-1503 is an investigational medicine, being studied as a potential treatment for atopic dermatitis (ad).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Part A:
- 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.
- Part B:
You likely can't join if
- Part A and B:
- Significant health issues, such as positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen...
- 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
See the full eligibility criteria
- Part A:
- 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.
- Part B:
- 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;
- Affected Body Surface Area (BSA)≥ 10%;
- vIGA-AD™ score ≥ 3
- History of an inadequate response to treatment with topical medications
- Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.
- Negative pregnancy tests for women of childbearing potential.
- Part A and B:
- 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.
- For Part B only:
- Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or might interfere with study assessments.
- Uncontrolled chronic disease that might require bursts of oral corticosteroids.
- Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Auckland, Auckland, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Auckland, Auckland, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.