About this trial
This is a phase 1, single dose, randomized, open-label, parallel-group study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of ZL-1503 and to explore its PD biomarkers following a single subcutaneous (SC) or intravenous (IV) administration in healthy volunteers.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ZL-1503
- ZL-1503
- ZL-1503