Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZT003 Injection Following Single and Multiple Subcutaneous Administration in Healthy Volunteers/Overweight or Obese Volunteers

Korábbi kezelés

• 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.

Más betegség

• 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.

Laborértékek

• 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.

Egyéb

• Pregnant or lactating females, or females planning to become pregnant during the study period.

• 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.