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

NCT07235384 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ZL-1503-001
• Study Type: interventional
• Target: 84
• Locations: 3 countries
• Sites: 12

Brief 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)

Conditions

Atopic Dermatitis (AD)

Keywords

Atopic Dermatitis

Outcome Measures

Primary Outcomes (5)

• Number of participants with adverse events (AEs)

  Up to 48 weeks after last intervention

• Number of participants with serious adverse events (SAEs)

  Up to 48 weeks after last intervention

• Number of participants with clinical laboratory abnormalities

  Up to 48 weeks after last intervention

• Number of participants with vital sign abnormalities

  Up to 48 weeks after last intervention

• Number of participants with electrocardiogram (ECG) abnormalities

  Up to 48 weeks after last intervention

Study Arms (2)

ZL-1503: Participants will receive single ascending doses of ZL-1503

EXPERIMENTAL

Part A: Single Ascending Dose (SAD)

Drug: ZL-1503; Drug: Placebo

ZL-1503: Participants will receive multiple ascending doses of ZL-1503

EXPERIMENTAL

Part B: Multiple Ascending Dose (MAD)

Drug: ZL-1503; Drug: Placebo

Interventions

ZL-1503 DRUG

Healthy volunteers will receive ZL-1503.

ZL-1503: Participants will receive single ascending doses of ZL-1503

Placebo DRUG

Healthy volunteers will receive placebo.

ZL-1503: Participants will receive single ascending doses of ZL-1503

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zai Lab (Shanghai) Co., Ltd.: lead

Study Sites (12)

Veracity Clinical Research

Woolloongabba, Queensland, Australia

RECRUITING

Skin Health Institute

Carlton, Victoria, Australia

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 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

Momentum Hutt Valley

Upper Hutt, Wellington Region, New Zealand

RECRUITING

Momentum Kapiti

Waikanae, Wellington Region, New Zealand

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

ZaiLab Medical Director

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): December 28, 2027
• Last Updated: August 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4); AU (2); NZ (6)