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RECRUITINGPHASE1

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

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)

NCT07235384•Zai Lab (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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;
+5 more criteria

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.
•5. History of drug abuse or addiction within 6 months prior to screening
•6. Current smoker or use of any nicotine or tobacco containing products within the last 6 months prior to dosing.
•7. 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 more criteria

Locations (1)

ZaiLab Site 18001

Auckland, Auckland, New Zealand

Key Dates

Start Date

December 1, 2025

Primary Completion Date

December 28, 2027

Completion Date

December 28, 2027

Last Updated

December 19, 2025

Enrollment

ESTIMATED participants

Conditions

Atopic Dermatitis (AD)

Interventions

ZL-1503

DRUG

Placebo

DRUG

ZL-1503

DRUG

Placebo

DRUG

Contacts

ZaiLab Medical Director

CONTACT

+86 021-61632588 ZaiLab_1503-001_StudyTeam@zailaboratory.com

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis

Effect of an Emollient Cream Containing a Milk Bioactive Peptide on Clinical Signs, Pruritus and Bacterial Colonization of Mild Atopic Dermatitis Skin Lesions in Pediatric Population

Herbal Ointment in Treating Atopic Dermatitis Topically

Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment with 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis

Clinical Evaluation of Skin Microbiome an Over-The-Counter (OTC) Drug for Atopic Dermatitis

Study of ENV-294 in Healthy Adults and in Adults With Moderate-to-Severe Atopic Dermatitis