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

NCT ID: NCT07235384

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-12-28

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)

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

Conditions

Atopic Dermatitis (AD)

Keywords

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Part A: Single Ascending Dose (SAD)

Group Type: EXPERIMENTAL

ZL-1503

Intervention Type: DRUG

Healthy volunteers will receive ZL-1503.

Placebo

Intervention Type: DRUG

Healthy volunteers will receive placebo.

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

Part B: Multiple Ascending Dose (MAD)

Group Type: EXPERIMENTAL

ZL-1503

Intervention Type: DRUG

Participants with moderate to severe atopic dermatitis will receive ZL-1503.

Placebo

Intervention Type: DRUG

Participants with moderate to severe atopic dermatitis will receive placebo.

Interventions

ZL-1503

Healthy volunteers will receive ZL-1503.

Intervention Type: DRUG

Placebo

Healthy volunteers will receive placebo.

Intervention Type: DRUG

ZL-1503

Participants with moderate to severe atopic dermatitis will receive ZL-1503.

Intervention Type: DRUG

Placebo

Participants with moderate to severe atopic dermatitis will receive placebo.

Intervention Type: DRUG

Eligibility Criteria

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.

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. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zai Lab (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ZaiLab Site 18001

Auckland, Auckland, New Zealand

Site Status: RECRUITING

Countries

New Zealand

Central Contacts

ZaiLab Medical Director

Role: CONTACT

Phone: +86 021-61632588

Email: ZaiLab_1503-001_StudyTeam@zailaboratory.com

Other Identifiers

ZL-1503-001

Identifier Type: -

Identifier Source: org_study_id