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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZai Lab (Shanghai) Co., Ltd.

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

Treatment groups

36 Participants
are divided into 3 treatment groups

Sponsors and collaborators