Menu
Recruiting NCT07235384

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

Phase I Interventional Atopic Dermatitis (AD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ZL-1503, Placebo, ZL-1503, Placebo.
Who it may be relevant to
Registry conditions: Atopic Dermatitis (AD). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, China, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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 (AD)

Overview

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)

Detailed description

The study consists of two parts:

* Part A: single ascending dose in healthy volunteers * Part B: multiple ascending doses in adult participants with moderate to severe AD

Interventions

  • Drug ZL-1503
    Healthy volunteers will receive ZL-1503.
  • Drug Placebo
    Healthy volunteers will receive placebo.
  • Drug ZL-1503
    Participants with moderate to severe atopic dermatitis will receive ZL-1503.
  • Drug Placebo
    Participants with moderate to severe atopic dermatitis will receive placebo.

Primary outcome measures

  • Number of participants with adverse events (AEs) [Time frame: Up to 48 weeks after last intervention]
  • Number of participants with serious adverse events (SAEs) [Time frame: Up to 48 weeks after last intervention]
  • Number of participants with clinical laboratory abnormalities [Time frame: Up to 48 weeks after last intervention]
  • Number of participants with vital sign abnormalities [Time frame: Up to 48 weeks after last intervention]
  • Number of participants with electrocardiogram (ECG) abnormalities [Time frame: Up to 48 weeks after last intervention]

Eligibility criteria

Inclusion 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

New Zealand · 6 centers
  • Aotearoa Clinical Trials — Auckland
  • Momentum Auckland — Takapuna
  • Momentum Hamilton — Hamilton
  • Momentum Palmerston North — Palmerston North
  • Momentum Hutt Valley — Upper Hutt
  • Momentum Kapiti — Waikanae
China · 4 centers
  • Peking University Third Hospital — Beijing
  • Shandong Provincial Dermatology Hospital — Jinan
  • Shanghai Skin Disease Hospital — Shanghai
  • Hangzhou First People's Hospital — Hangzhou
Australia · 2 centers
  • Veracity Clinical Research — Woolloongabba
  • Skin Health Institute — Carlton

Identifiers

NCT: NCT07235384 · ZL-1503-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗