[Translation] A single-center, randomized, double-blind, parallel-controlled, dose-escalation phase I clinical trial was conducted to evaluate the safety, tolerability, and pharmacokinetic characteristics of a single dose of anti-five-step snake venom in healthy adult subjects.
主要目的:评估健康成年受试者单次静脉注射抗五步蛇毒血清后的安全性和耐受性。次要目的:1.评估健康成年受试者单次静脉注射抗五步蛇毒血清后的药代动力学(PK)特征;2.评估健康成年受试者单次静脉注射抗五步蛇毒血清后的免疫原性特征。
[Translation] Primary objective: To evaluate the safety and tolerability of a single intravenous injection of anti-Five-Step Snake venom serum in healthy adult subjects. Secondary objectives: 1. To evaluate the pharmacokinetic (PK) characteristics of a single intravenous injection of anti-Five-Step Snake venom serum in healthy adult subjects; 2. To evaluate the immunogenicity characteristics of a single intravenous injection of anti-Five-Step Snake venom serum in healthy adult subjects.