A Phase 1 Study to Evaluate Pharmacokinetics, Safety and Tolerability of ZL-1503 in Healthy Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ZL-1503, ZL-1503, ZL-1503.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- New Zealand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Randomized, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-1503 Following a Single Dose of Subcutaneous or Intravenous Administration in Healthy Volunteers.
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.
Interventions
- Drug ZL-1503
Healthy volunteers will receive a single intravenous dose of ZL-1503. - Drug ZL-1503
Healthy volunteers will receive a single subcutaneous administration at Dose 1. - Drug ZL-1503
Healthy volunteers will receive a single subcutaneous administration at Dose 2.
Primary outcome measures
- Maximum plasma concentration (Cmax) [Time frame: From Predose to Day 337]
- Time to maximum concentration (Tmax) [Time frame: From Predose to Day 337]
- Area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) [Time frame: From Predose to Day 337]
- Area under the plasma concentration-time curve from time zero to infinity (AUCinf) [Time frame: From Predose to Day 337]
- Apparent terminal elimination half-life (t1/2) [Time frame: From Predose to Day 337]
- Apparent total body clearance (CL/F) [Time frame: From Predose to Day 337]
- Apparent volume of distribution (Vz/F) [Time frame: From Predose to Day 337]
- Steady State Volume of distribution (Vss IV) [Time frame: From Predose to Day 337]
- Total Body Clearance (CL IV) [Time frame: From Predose to Day 337]
- Absolute bioavailability (F) [Time frame: From Predose to Day 337]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
New Zealand · 1 center
- ZaiLab Site 18001 — Auckland
Identifiers
NCT: NCT07658482 · ZL-1503-002