Phase 1 study of TM5614 -placebo controlled multiple dose study in male healthy adult subjects- - Placebo controlled multiple dose study in male healthy adult subjects (TM5614-2)

Tohoku university school of medicine, molecular medicine and therapy0 个研究点目标入组 18 人开始时间: 2017年1月6日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1.Male Japanese 2.From 20 years old to 45 years old at voluntary written consent 3.From 50.0 kg to 85.0 kg and from 18.5 to 25.0 of BMI at screening 4.Voluntary written consent by themselves is given before screening. 1.History of liver diseases, cardiovascular diseases, respiratory diseaases, gastroenteric diseases, kidney diseases, cerebralvascular diseases, cancer 2.Known hypersensitivity to some drugs and foods 3.Treatment by other doctors (included supplement) within 14 days before screening 4.Treatment with any investigational compound within 120 days before screening 5.History of TM5614 administration 6.History of blood taken *>= 1200ml of all blood within 1 year before screening *>= 400ml of all blood with 84 days before screening *>= 200ml of all blood within 14 days before screening 7.Smoking status and treatment with anti-nicotine agents 8.Known active chronic hepatitis B or C, active syphilis and human immunodeficiency virus infection 9.Abuse of alcohol or drugs (included past history) 10.Bleeding, in the tendency to bleeding, and family history and past history of bleeding disorders 11.Somebody who are directed by principle investigator and employees in Hamamatsu University hospital 12.Any serious medical or psychiatric illness that could, in the opinion of the investigator, potentially interfere with the completion of treatment according to this protocol.

发起方

Tohoku university school of medicine, molecular medicine and therapy