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NCT Number: NCT07658482

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ZaiLab Site 18001

Auckland, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZL-1503

Drug

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

Primary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: From Predose to Day 337

  2. Time to maximum concentration (Tmax)

    Time frame: From Predose to Day 337

  3. Area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)

    Time frame: From Predose to Day 337

  4. Area under the plasma concentration-time curve from time zero to infinity (AUCinf)

    Time frame: From Predose to Day 337

  5. Apparent terminal elimination half-life (t1/2)

    Time frame: From Predose to Day 337

  6. Apparent total body clearance (CL/F)

    Time frame: From Predose to Day 337

  7. Apparent volume of distribution (Vz/F)

    Time frame: From Predose to Day 337

  8. Steady State Volume of distribution (Vss IV)

    Time frame: From Predose to Day 337

  9. Total Body Clearance (CL IV)

    Time frame: From Predose to Day 337

  10. Absolute bioavailability (F)

    Time frame: From Predose to Day 337

Study contacts

Contact information is provided by the study sponsor or research team.

ZaiLab Medical Director

CONTACT

[email protected]

+86 021-61632588

Sponsors and collaborators

Lead sponsor

Zai Lab (Shanghai) Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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