TRUE-1: Trial of Repurposed Unithiol for snakebite Envenoming Phase 1 (Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Kenyan Adults)

This package contains DMP, SAP and DSMB charter for the TRUE-1: Trial of Repurposed Unithiol for snakebite Envenoming Phase 1 (Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Kenyan Adults).

本数据包包含TRUE-1试验——用于蛇咬伤中毒的老药新用巯基化合物一期临床试验（即在健康肯尼亚成年人群中开展的安全性、耐受性、药代动力学及药效学研究）相关的数据管理计划（Data Management Plan, DMP）、统计分析计划（Statistical Analysis Plan, SAP）以及数据安全监查委员会（Data Safety Monitoring Board, DSMB）章程。