Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZT003 Injection Following Sin… (NCT07184502) | Clinical Trial Compass
RecruitingPhase 1
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZT003 Injection Following Single and Multiple Subcutaneous Administration in Healthy Volunteers/Overweight or Obese Volunteers
Australia72 participantsStarted 2025-10-16
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
2
Incidence of Serious Adverse Events (SAEs)
Timeframe: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
3
Incidence of Adverse Events of Special Interest (AESIs)
Timeframe: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
4
Incidence of Adverse Events Leading to Study Drug Discontinuation or Withdrawal
Timeframe: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
5
Incidence and Severity of Injection Site Reactions (ISRs)
Timeframe: From first dose (Day 1) through End of Treatment/EOT visit (Day 50)
6
Change from Baseline in Systolic Blood Pressure
Timeframe: From Screening (Day -35) through End of Treatment (Day 50).
. Thyroid function tests within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee.
Exclusion criteria
. 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.
7
Change from Baseline in Diastolic Blood Pressure
Timeframe: From Screening (Day -35) through End of Treatment (Day 50).
8
Change from Baseline in Pulse Rate
Timeframe: From Screening (Day -35) through End of Treatment (Day 50).
9
Change from Baseline in Body Temperature
Timeframe: From Screening (Day -35) through End of Treatment (Day 50).
10
Change from Baseline in Respiratory Rate
Timeframe: From Screening (Day -35) through End of Treatment (Day 50).
11
Change from Baseline in ECG Heart Rate
Timeframe: From Screening (Day -35) through End of Treatment (Day 50).
12
Change from Baseline in ECG PR Interval
Timeframe: From Screening (Day -35) through End of Treatment (Day 50).
13
Change from Baseline in ECG QRS Duration
Timeframe: From Screening (Day -35) through End of Treatment (Day 50).
14
Change from Baseline in ECG QT Interval
Timeframe: From Screening (Day -35) through End of Treatment (Day 50).
15
Change from Baseline in ECG Corrected QT Interval (QTcF)
Timeframe: From Screening (Day -35) through End of Treatment (Day 50).