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

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.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07658482

Enrollment

Registered

2026-06-22

Start date

2026-09-03

Completion date

2027-11-10

Last updated

2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Healthy volunteers

Brief summary

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

DRUGZL-1503

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Maximum plasma concentration (Cmax)	From Predose to Day 337
Time to maximum concentration (Tmax)	From Predose to Day 337
Area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)	From Predose to Day 337
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)	From Predose to Day 337
Apparent terminal elimination half-life (t1/2)	From Predose to Day 337
Apparent total body clearance (CL/F)	From Predose to Day 337
Apparent volume of distribution (Vz/F)	From Predose to Day 337
Steady State Volume of distribution (Vss IV)	From Predose to Day 337
Total Body Clearance (CL IV)	From Predose to Day 337
Absolute bioavailability (F)	From Predose to Day 337

Countries

New Zealand

Contacts

CONTACTZaiLab Medical Director

ZL-1503-002_StudyTeam@zailaboratory.com+86 021-61632588

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026