Tests ZL-1503 safety in healthy people and adults with atopic dermatitis
Tests the drug ZL-1503 in healthy adults and adults with moderate to severe atopic dermatitis.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Beijing, Fuzhou, Hangzhou, Jinan, Nanchang, and Shanghai, ChinaSee the 6 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07235384, who can take part
Where in China
- Peking University Third HospitalBeijing, ChinaTaking people
- The First Affiliated Hospital of Fujian Medical UniversityFuzhou, ChinaTaking people
- Hangzhou First People's HospitalHangzhou, ChinaTaking people
- Shandong Provincial Dermatology HospitalJinan, ChinaTaking people
- Dermatology Hospital of Jiangxi ProvinceNanchang, ChinaTaking people
- Shanghai Skin Disease HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zai Lab (Shanghai) Co., Ltd.
- Trial code
- NCT07235384
- Record updated
- 4 November 2026
- Original description
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)Read full original descriptionShow less
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)
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)
Inclusion: 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: 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; Smoke > 10 cigarettes or the equivalent (including electronic cigarettes) per day; 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, 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.