[Translation] A single-center, randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of a single dose of anti-viper venom serum in healthy Chinese subjects
主要目的:在单次给药条件下,评价健康受试者给予不同剂量的抗蝰蛇毒血清后的安全性和耐受性。
次要目的:1)评价抗蝰蛇毒血清在健康人体内的药代动力学特征。2)探索健康受试者静脉注射抗蝰蛇毒血清后体内免疫原性的变化。3)探索给药后受试者体内的抗蝰蛇毒血清对体外蛇毒毒素的中和能力的变化。
[Translation] Primary objective: To evaluate the safety and tolerability of different doses of antivenom in healthy subjects under single-dose conditions.
Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of antivenom in healthy humans. 2) To explore the changes in the immunogenicity of antivenom in healthy subjects after intravenous injection of antivenom. 3) To explore the changes in the neutralization ability of antivenom in subjects against in vitro snake venom toxins after administration.