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

Phase 1Not Yet RecruitingNCT07658482

Zai Lab (Shanghai) Co., Ltd.36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

ZL-1503DRUG

Healthy volunteers will receive a single intravenous dose of ZL-1503.

ZL-1503DRUG

Healthy volunteers will receive a single subcutaneous administration at Dose 1.

ZL-1503DRUG

Healthy volunteers will receive a single subcutaneous administration at Dose 2.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

Momentum Auckland

Takapuna, Auckland, New Zealand