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First human test of ZL-1503 begins to uncover how the body handles it

NCT ID NCT07658482

Knowledge-focused Sponsor: Zai Lab (Shanghai) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This early-stage trial is testing a new drug called ZL-1503 in healthy volunteers. The goal is to understand how the drug moves through the body, how safe it is, and how well people tolerate it after a single injection under the skin or into a vein. The study involves 36 healthy adults aged 18 to 65 and will help guide future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ZL-1503
What this could lead to
If successful, this study could provide key data to support further development of ZL-1503 for potential future use in patients.
What could go wrong
This is an early phase 1 trial in healthy volunteers, so results may not predict effects in patients. Side effects or lack of tolerability could halt development.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Momentum Auckland

    Takapuna, Auckland, New Zealand

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