Tests ZT003 injection safety in healthy and overweight adult volunteers
Tests ZT003 injection's safety and how the body handles it in healthy adults.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Brisbane and Melbourne, AustraliaSee the 2 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07184502, who can take part
Where in Australia
- Nucleus Network BrisbaneBrisbane, AustraliaTaking people
- Nucleus NetworkMelbourne, AustraliaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing QL Biopharmaceutical Co.,Ltd
- Trial code
- NCT07184502
- Record updated
- 27 July 2026
- Original description
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.Read full original descriptionShow less
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZT003 Injection in Healthy Volunteers and Overweight or Obese Volunteers
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.
Inclusion: 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.
Exclusion: 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; 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; Any history of significant allergy or hypersensitivity to any component of the investigational medicinal product (IMP); History of bleeding disorders or current use of anticoagulant therapy; 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; Pregnant or lactating females, or females planning to become pregnant during the study period.