[Translation] This is a single-center, randomized, double-blind, parallel-controlled, dose-escalation phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of a single dose of antivenom in healthy adult subjects.
主要目的:评估健康成年受试者单次静脉注射抗蝮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蝮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蝮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 antivenom in healthy adult subjects. Secondary objectives: 1. To evaluate the pharmacokinetic (PK) characteristics of antivenom in healthy adult subjects after a single intravenous injection; 2. To evaluate the immunogenicity characteristics of antivenom in healthy adult subjects after a single intravenous injection.