Study of GR2303 Injection Safety and Effects in Healthy Adults Aged 18 to 45

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and immune response of GR2303 injection in healthy adult subjects aged 18 to 45 years. This randomized, double-blind, placebo-controlled Phase 1 study aims to gather initial information on how the body processes GR2303 and its potential effects compared to placebo. The study is sponsored by Genrix Shanghai Biopharmaceutical Co., Ltd. Participants will be randomly assigned to one of several groups receiving either a single or multiple doses of GR2303 injection or placebo. Each subject will be enrolled in only one group, and dosing schedules differ between groups to evaluate different administration patterns. Both GR2303 and placebo are given by injection under controlled, blinded conditions to ensure unbiased assessment. During the study, participants will undergo safety monitoring for adverse events over a 16-week period. Researchers will also measure drug concentration peaks, time to peak concentration, half-life, and immune reactions against the drug. Subjects will complete study visits and evaluations according to the assigned dosing group, with careful observation to track tolerability and pharmacological responses throughout the trial.

A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2303 in Healthy Adult