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

NCT07658482 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-06-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Zai Lab (Shanghai) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-03
Primary Completion
2027-02-06
Completion
2027-11-10

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07658482 on ClinicalTrials.gov