A Phase 1 Study to Evaluate Pharmacokinetics, Safety and Tolerability of ZL-1503 in Healthy Volunteers

Starting soon · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT07658482

Run by

Zai Lab (Shanghai) Co., Ltd.

People needed

36

Starts

2026-09-03

Expected to finish

2027-11-10

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• ZaiLab Site 18001 — Auckland, Auckland, New Zealand

Full record on ClinicalTrials.gov

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