New drug ZT003 tested for safety in first human trial
NCT ID NCT07184502
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Nucleus Network
NOT_YET_RECRUITINGMelbourne, Australia
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Nucleus Network Brisbane
RECRUITINGBrisbane, Queensland, Australia
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