Single- and multiple-dose testing of ZL-1503 in adults with moderate to severe atopic dermatitis and healthy volunteers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled Phase 1/1b trial uses single ascending dose (SAD) and multiple ascending dose (MAD) cohorts to measure safety, tolerability, and pharmacokinetics of ZL-1503. Part A enrolls healthy volunteers for single ascending doses, while Part B enrolls adults with moderate-to-severe atopic dermatitis for multiple ascending doses. Participants are randomized to receive ZL-1503 or placebo and undergo clinical exams, laboratory monitoring, and scheduled PK sampling with dose-escalation guided by safety data. Results will inform dosing and go/no-go decisions for later-stage studies.

Why it matters

Who can join: the full rules

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, in the investigator's judgment, make the participant unsuitable for study participation.
  5. History of drug abuse or addiction within 6 months prior to screening
  6. 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.
  4. Smoke \> 10 cigarettes or the equivalent (including electronic cigarettes) per day.

Where it's running

• Veracity Clinical Research
  Woolloongabba, Queensland, Australia Recruiting
• Skin Health Institute
  Carlton, Victoria, Australia Recruiting
• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Fujian Medical University
  Fuzhou, Fujian, China Recruiting
• Dermatology Hospital of Jiangxi Province
  Nanchang, Jiangxi, China Recruiting
• Shandong Provincial Dermatology Hospital
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: ZaiLab Medical Director
• Email: ZaiLab_1503-001_StudyTeam@zailaboratory.com
• Phone: +86 021-61632588

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.