RecruitingPhase 1interventionalRules rewrite

Phase 1: testing ZL-1503 for Atopic Dermatitis (AD)

This is a phase 1/1b randomly assigned, double blind, compared with a dummy treatment, single dose escalation (SAD) and multiple dose escalation (MAD) study to measure the safety, tolerability, and pharmacokinetics (PK) of ZL-1503 in healthy volunteers and participants with moderate to severe atopic dermatitis (AD)

Official registry: https://clinicaltrials.gov/study/NCT07235384 · Zai Lab (Shanghai) Co., Ltd. · enrollment listed as 84

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ZL-1503, Placebo, or ZL-1503. The registry lists allocation as randomized. This is a phase 1/1b randomly assigned, double blind, compared with a dummy treatment, single dose escalation (SAD) and multiple dose escalation (MAD) study to measure the safety, tolerability, and pharmacokinetics (PK) of ZL-1503 in healthy volunteers and participants with moderate to severe atopic dermatitis (AD)

They plan to enroll about 84 people at 14 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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)

Interventions: ZL-1503, Placebo, ZL-1503, Placebo

Primary outcome (registry wording): Number of participants with adverse events (AEs)

Who it is for (from inclusion criteria)

Ages 18 Years to 65 Years
Healthy male and female volunteers, 18-65 years of age
Body mass index (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;
body-mass index (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:

Who the registry excludes

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, in the investigator's judgment, make the participant unsuitable for study participation
History of drug abuse or addiction within 6 months prior to screening
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

Public study contact (from the registry)

ZaiLab Medical Director

+86 021-61632588

ZaiLab_1503-001_StudyTeam@zailaboratory.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

14 listed

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)
Shanghai Skin Disease Hospital — Shanghai, Shanghai Municipality, China (recruiting)
Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (recruiting)
Aotearoa Clinical Trials — Auckland, Auckland, New Zealand (recruiting)
Momentum Auckland — Takapuna, Auckland, New Zealand (recruiting)
Momentum Hamilton — Hamilton, Hamilton, New Zealand (recruiting)
Momentum Palmerston North — Palmerston North, Mananwatu, New Zealand (recruiting)

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FAQ about this NCT record

Is NCT07235384 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07235384?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07235384?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary