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.
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.
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.
Sequential
ZT003 - Part1 (Single ascending dose )
DrugZT003 or Placeo is administered as a single subcutaneous injection at different dose levels.
ZT003 - Part 2(Multiple ascending dose )
DrugZT003 or Placeo administered as multiple subcutaneous injections at different dose levels.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Incidence of Serious Adverse Events (SAEs)
Incidence of Adverse Events of Special Interest (AESIs)
Incidence of Adverse Events Leading to Study Drug Discontinuation or Withdrawal
Plasma Cmax of ZT003
Plasma Tmax of ZT003
AUC from time zero to the last quantifiable concentration of ZT003
AUC from time zero extrapolated to infinity of ZT003
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