Phase I Randomized, Double-Blind, Placebo-Controlled Study of Single-Dose SV003 to Assess Safety and Drug Effects in Healthy Adults Aged 18 to 45

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of SV003 in healthy adult participants aged 18 to 45 years. This randomized, double-blind, placebo-controlled Phase I clinical trial aims to understand how SV003 behaves in the body and its safety profile in individuals without active or chronic diseases. The study is sponsored by Shanghai Synvida Biotechnology Co., Ltd. and focuses on healthy volunteers. Participants will receive a single dose of either the study drug SV003 or a placebo. The trial uses a randomized assignment to one of these two groups and includes a double-blind design, meaning neither participants nor researchers know who receives which treatment during the study. The dosing involves a single administration, after which participants will be monitored. During the approximately three-month study period, participants will undergo regular assessments to track any treatment-emergent adverse events. Researchers will also measure pharmacokinetic parameters such as peak plasma concentration, peak time, area under the plasma concentration curve, half-life, and immunogenicity. Participants will be closely monitored for safety and tolerability throughout the study to gather comprehensive data on SV003s effects.

A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants.