Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZT003 Injection Following Single and Multiple Subcutaneous Administration in Healthy Volunteers/Overweight or Obese Volunteers
Trial Parameters
Brief 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.
Eligibility Criteria
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 parti