Phase I Study to Assess Safety, Tolerability, and Pharmacokinetics of Single-Dose SV001 Compared to Placebo in Healthy Chinese Adults Aged 18 to 45

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and immune response of a drug called SV001 compared to a placebo in healthy adult volunteers from China. This early phase 1, randomized, double-blind, and placebo-controlled study aims to understand how SV001 behaves in the body and whether it causes any adverse effects. The study focuses on adults aged 18 to 45 years who are in good health. Participants will receive a single dose of either SV001 or a placebo. The study uses a dose-escalation design, meaning doses may increase to assess safety. The trial is conducted at a single center and uses a quadruple-blind method where participants, care providers, investigators, and outcome assessors are unaware of which treatment is given. The intervention period includes administration of the study drug followed by monitoring. During the study, participants will undergo various assessments including monitoring for any treatment-emergent adverse events, measuring drug levels in the blood over time, and checking for immune responses to SV001. These evaluations will take place over approximately one year. Researchers will also monitor participants overall health, respiratory function, and conduct laboratory tests to ensure safety throughout the trial.

A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.