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Tests treatment safety and results for Healthy
Official title Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZT003 Injection Following Single and Multiple Subcutaneous Administration in Healthy Volunteers/Overweight or Obese Volunteers
ClinicalTrials.gov ID: NCT07184502
What this study is testing
What is ZT003?
ZT003 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1, randomized, double-blind, placebo-controlled, single-center study designed to evaluate the safety, tolerability, and pharmacokinetics of ZT003 following subcutaneous administration in healthy adult participants. The study includes both single ascending dose (SAD) and multiple ascending dose (MAD) parts.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Healthy male and female participants, aged 18 to 65 years at the time of screening.
- Body weight \>50 kg to \<130 kg, and BMI between 22.0 and 45.0 kg/m square.
- Medically healthy, with no clinically significant abnormalities in medical history, physical examination, vital signs, ECG, or clinical laboratory...
- Females of childbearing potential must use highly effective contraception and have a negative pregnancy test at screening and Day -1.
- Male participants must agree to use acceptable contraception from screening through at least 90 days after the last dose.
You likely can't join if
- History or presence of any clinically significant disease or disorder that may put the participant at risk or interfere with study assessments.
- Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or HIV antibody at screening.
- History of drug or alcohol abuse within 12 months prior to screening.
- Use of prescription drugs, over-the-counter medications, herbal products, or supplements within 14 days (or 5 half-lives) prior to first dose unless...
- Participation in another clinical study with an investigational product within 30 days or 5 half-lives of the investigational product before dosing.
- Any history of significant allergy or hypersensitivity to any component of the investigational medicinal product (IMP).
See the full eligibility criteria
- Healthy male and female participants, aged 18 to 65 years at the time of screening.
- Body weight \>50 kg to \<130 kg, and BMI between 22.0 and 45.0 kg/m square.
- Medically healthy, with no clinically significant abnormalities in medical history, physical examination, vital signs, ECG, or clinical laboratory assessments, as judged by the Investigator.
- Females of childbearing potential must use highly effective contraception and have a negative pregnancy test at screening and Day -1.
- Male participants must agree to use acceptable contraception from screening through at least 90 days after the last dose.
- Able to understand and comply with study procedures and provide written informed consent.
- Thyroid function tests within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee.
- History or presence of any clinically significant disease or disorder that may put the participant at risk or interfere with study assessments.
- Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or HIV antibody at screening.
- History of drug or alcohol abuse within 12 months prior to screening.
- 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.
- Participation in another clinical study with an investigational product within 30 days or 5 half-lives of the investigational product before dosing.
- Any history of significant allergy or hypersensitivity to any component of the investigational medicinal product (IMP).
- Clinically significant ECG abnormalities, including QTc \>450 ms (males) or \>470 ms (females) at screening.
- Abnormal clinical laboratory results at screening considered clinically significant by the Investigator.
- History of bleeding disorders or current use of anticoagulant therapy.
- Pregnant or lactating females, or females planning to become pregnant during the study period.
The study team makes the final eligibility decision.
Where it's taking place
- Brisbane, Queensland, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brisbane, Queensland, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.