Preclinical development of novel small molecule malaria drugs that overcome drug

描述（由申请人提供）：由于耐药寄生虫的传播，疟疾造成的全球健康问题变得更加困难。该项目启动一种或多种候选药物的临床前开发，这些候选药物来自一种创新的新型强效抗疟药，旨在克服耐药性。我们开发了一种可口服且价格低廉的新型药物，对氯喹耐药疟疾和氯喹敏感疟疾都起作用。一小部分经过精心挑选的候选药物将通过临床前测试，最终选择一种药物用于与美国食品和药物管理局（fda）进行新药研究前会议。在美国食品和药物管理局的指导下，本研究的第二阶段将在大鼠和猴子身上进行药代动力学、药效学、药理学和毒性评估。总体目标将是完成临床前研究，从而批准研究性新药（IND）申请，用于1期人体临床试验。

DESCRIPTION (provided by applicant): The worldwide health problem created by malaria has been made more difficult by the spread of drug- resistant parasites. This project initiates preclinical development of one or more candidate(s) from an innovative new class of potent antimalarials designed to overcome drug resistance. We have developed an orally available and inexpensive class of novel drugs that act against both chloroquine-resistant and chloroquine-sensitive malaria. A small set of carefully-selected candidates will be advanced through preclinical testing, leading to the selection of a single drug for a pre-Investigational New Drug meeting with the Food and Drug Administration. With guidance from the Food and Drug Administration, pharmacokinetics, pharmacodynamics, pharmacology, and toxicity evaluations will be performed in both rats and monkeys in phase II of this work. The overall goal will be completion of preclinical studies leading to approval of the Investigative New Drug (IND) application for a drug to be used in a Phase-1 human clinical trial.