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New drug ZT003 tested for safety in first human trial

NCT ID NCT07184502

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Updated 2 times

Summary

This early-stage study tests the safety and tolerability of an investigational drug called ZT003 in healthy adults and those who are overweight or obese. About 76 participants will receive either the drug or a placebo to check for side effects and how the drug moves through the body. The goal is to gather safety data, not to treat any disease.

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 72 people

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

Started

Oct 2025

Expected to finish

Apr 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: 1. Healthy male and female participants, aged 18 to 65 years at the time of screening. 2. Body weight \>50 kg to \<130 kg, and BMI between 22.0 and 45.0 kg/m square. 3. Medically healthy, with no clinically significant abnormalities in medical history, physical examination, vital signs, ECG, or clinical laboratory assessments, as judged by the Investigator. 4. Females of childbearing potential must use highly effective contraception and have a negative pregnancy test at screening and Day -1. 5. Male participants must agree to use acceptable contraception from screening through at least 90 days after the last dose. 6. Able to understand and comply with study procedures and provide written informed consent. 7. Thyroid function tests within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee. Exclusion Criteria: 1. History or presence of any clinically significant disease or disorder that may put the participant at risk or interfere with study assessments. 2. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or HIV antibody at screening. 3. History of drug or alcohol abuse within 12 months prior to screening. 4. Use of prescription drugs, over-the-counter medications, herbal products, or supplements within 14 days (or 5 half-lives) prior to first dose unless deemed acceptable by the Investigator. 5. Participation in another clinical study with an investigational product within 30 days or 5 half-lives of the investigational product before dosing. 6. Any history of significant allergy or hypersensitivity to any component of the investigational medicinal product (IMP). 7. Clinically significant ECG abnormalities, including QTc \>450 ms (males) or \>470 ms (females) at screening. 8. Abnormal clinical laboratory results at screening considered clinically significant by the Investigator. 9. History of bleeding disorders or current use of anticoagulant therapy. 10. Pregnant or lactating females, or females planning to become pregnant during the study period.

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As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 sites. 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

  • Nucleus Network

    NOT_YET_RECRUITING

    Melbourne, Australia

  • Nucleus Network Brisbane

    RECRUITING

    Brisbane, Queensland, Australia

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