Safety and tolerability in healthy volunteers and participants with moderate to severe atopic dermatitis Skin and Connective Tissue Diseases
Conditions
Interventions
Healthy volunteers in the SAD part of the study will enrol sequentially into 4 single dose cohorts from New Zealand. Two additional cohorts of Chinese healthy volunteers will enrol sequentially in Chi
Sponsors
Zai Lab (Shanghai) Co., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Part A (SAD): A1. Healthy male and female volunteers, 18-65 years of age A2. Body mass index (BMI) between = 18.5 and < 32.5 kg/m² A3. Negative pregnancy tests for women of childbearing potential Part B (MAD): B1. 18-65 years of age B2. BMI between =18.5 and <40.0 kg/m² B3. Have a diagnosis of AD at least 12 months prior to Day 1 B4. Moderate-to-severe AD at Screening and Baseline visit, defined as: B4.1. Eczema Area and Severity Index (EASI) score = 1 B4.2. Affected Body Surface Area (BSA)= 10% B4.3. vIGA-ADTM score = 3 B5. History of an inadequate response to treatment with topical medications B6. Average peak pruritus numeric rating scale (PP-NRS) score =4 in the 7 days before randomization B7. Negative pregnancy tests for women of childbearing potential
Exclusion 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 virus (HBV), 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. Part B only: B8. Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or might interfere with study assessments. B9. Uncontrolled chronic disease that might require bursts of oral corticosteroids. B10. Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of ZL-1503 assessed using incidence of Adverse Events (AEs) and serious adverse events (SAEs) coded based on the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE). Incidence of clinically significant laboratory findings (Chemistry, Hematology. Urinalysis). Incidence of clinically significant vital signs include pulse rate measured via brachial/radial artery, blood pressure through digital Sphygmomanometer, body temperature, and respiratory rate. Incidence of clinically significant changes in electrocardiograms. Timepoints: Part A (SAD): Adverse events, clinical laboratory and blood and urine samples, vital signs and ECGs from screening up to Day 337. Part B (MAD): Adverse events, clinical laboratory and blood and urine samples, vital signs and ECGs from screening up to Day 365. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PK parameters of ZL-1503 may include, but are not limited to, maximum serum concentration (Cmax), time to reach maximum concentration (Tmax), area under the concentration-time profile (AUC), half-life (t1/2), volume of distribution at steady-state (Vss), clearance (CL) and accumulation ratio, as applicable. Timepoint: Part A (SAD): PK samples will be collected from pre-dose on Day 1 up to Day 337. Part B (MAD): PK samples will be collected from pre-dose on Day 1 up to Day 365. 2. ZL-1503 Immunogenicity measured using the incidence of anti-drug antibody (ADA). Timepoint: Part A (SAD): ADA samples will be collected from pre-dose on Day 1 up to Day 337. Part B (MAD): ADA samples will be collected from pre-dose on Day 1 up to Day 365. | — |
Countries
China, New Zealand
Contacts
Public ContactZai Lab Study Team
Outcome results
None listed