Actively Recruiting
A Phase 1/1b Randomized, Double Blind, Placebo-controlled, Single and Multiple Dose Escalation Study to Evaluate the 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and pharmacokinetics of a drug called ZL-1503 in both healthy volunteers and adults with moderate to severe atopic dermatitis (AD). This phase 1/1b randomized, double-blind, placebo-controlled study includes participants aged 18 to 65 years. The study aims to better understand how ZL-1503 behaves in the body and its safety profile in these groups. The study has two parts: Part A involves healthy volunteers receiving single ascending doses of ZL-1503 or placebo. Part B includes adults with moderate to severe AD receiving multiple ascending doses of ZL-1503 or placebo. Both parts focus on dose escalation to assess safety and drug behavior. The treatments are given in a controlled setting to monitor effects carefully. Participants will undergo safety evaluations including monitoring for adverse events, lab tests, vital signs, and electrocardiograms up to 48 weeks after the last dose. Researchers will track any clinical abnormalities and serious events during this period. The study includes regular assessments to measure the impact of ZL-1503 and ensure participant well-being throughout the trial duration.
CONDITIONS
Brief 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...
- Healthy male and female volunteers aged 18 to 65 years for Part A
- 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
- Adults aged 18 to 65 years for Part B
- 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 for Part B
- Moderate to severe atopic dermatitis at screening and baseline, defined by Eczema Area and Severity Index (EASI) score of 16 or higher, affected Body Surface Area (BSA) of 10% or more, and vIGA-AD™ score of 3 or higher for Part B
- History of inadequate response to topical treatments for Part B
- Average peak pruritus numeric rating scale (PP-NRS) score of 4 or higher in the 7 days before randomization for Part B
- Negative pregnancy tests for women of childbearing potential in Part B
You will not qualify if you...
- 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 prior to 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 before dosing
- Presence of skin conditions or comorbidities that may confuse the diagnosis of atopic dermatitis or interfere with study assessments (Part B only)
- Uncontrolled chronic disease requiring oral corticosteroid bursts (Part B only)
- Other medical, psychiatric, or social reasons as determined by the investigator (Part B only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies by part: Part A involves single doses; Part B involves multiple doses over a defined period.
Participants receive either single or multiple ascending doses of the study drug or placebo to evaluate safety, tolerability, and pharmacokinetics.
1 baseline visit and multiple visits during dosing depending on cohort assignment
Duration - Up to 48 weeks after last intervention
Participants are monitored for safety and adverse events after the last dose of the study drug or placebo for up to 48 weeks.
Periodic visits for safety assessments
Trial Site Locations
Total: 1 location
1
ZaiLab Site 18001
Auckland, Auckland, New Zealand
Actively Recruiting
Research Team
Z
ZaiLab Medical Director
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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