Preclinical development of novel small molecule malaria drugs that overcome drug

克服药物障碍的新型小分子疟疾药物的临床前开发

基本信息

批准号：
8317596
负责人：
DAVID H PEYTON
金额：
$ 30万
依托单位：
DESIGNMEDIX, INC.
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-01 至 2014-04-14
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8317596
关键词：
Abbreviations Acute Adverse effects Antimalarials Back Carrier Proteins Child Chloroquine Chloroquine resistance Clinical Research Clinical Trials Combined Modality Therapy Development Disease Dose Drug Design Drug Kinetics Drug resistance Ethers Evaluation Funding Future Gene Proteins Goals Grant Health Health Sciences Human In Vitro Inhibitory Concentration 50 Institutes Intravenous Investigational Drugs Lead Lethal Dose 50 Link Malaria Monkeys Multi-Drug Resistance Mus National Institute of Allergy and Infectious Disease Neuraxis Oral cavity Oregon Parasites Pharmaceutical Preparations Pharmacodynamics Pharmacology Phase Plasmodium falciparum Preclinical Drug Development Preclinical Testing Predisposition Pregnant Women Pump Rattus Research Contracts Research Design Resistance Small Business Technology Transfer Research Structure Structure-Activity Relationship Technology Therapeutic Index Toxic effect Translational Research Tropical Disease United States Food and Drug Administration Universities Vacuole Work chemosensitizing agent chemotherapy cost cytotoxicity design drug candidate drug development fitness flexibility in vivo innovation killings meetings mouse model novel pre-clinical preclinical evaluation preclinical study programs research and development resistant strain response single molecule small molecule

项目摘要

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.

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。该项目启动了一种或多种候选药物的临床前开发，该候选药物是一种创新的新型强效抗疟药，旨在克服耐药性。我们开发了一种口服且廉价的新型药物，可对抗氯喹耐药性和氯喹敏感型疟疾。一小组精心挑选的候选药物将通过临床前测试进行推进，从而为与美国食品和药物管理局举行的新药研究前会议选择一种药物。在美国食品和药物管理局的指导下，这项工作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。总体目标是完成临床前研究，从而批准用于一期人体临床试验的新药研究 (IND) 申请。