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

NCT07658482 | Not Yet Recruiting Phase 1

• 1 other identifier: ZL-1503-002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (3)

ZL-1503 (Intravenous Administration)

EXPERIMENTAL

Drug: ZL-1503

ZL-1503 (Subcutaneous Dose 1)

EXPERIMENTAL

Drug: ZL-1503

ZL-1503 (Subcutaneous Dose2)

EXPERIMENTAL

Drug: ZL-1503

Interventions

ZL-1503 DRUG

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

ZL-1503 (Intravenous Administration)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zai Lab (Shanghai) Co., Ltd.: lead

Study Sites (1)

ZaiLab Site 18001

Auckland, Auckland, New Zealand

Location

Central Study Contacts

ZaiLab Medical Director

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): September 3, 2026
• Primary Completion (Estimated): February 6, 2027
• Study Completion (Estimated): November 10, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)