A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Injectable Favipiravir in Healthy Subjects

Sakurai Tsutomu0 个研究点目标入组 50 人开始时间: 2021年7月12日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•(1) Subjects between 20 and 39 years of age (inclusive) at informed consent
•(2) Gender: Male subjects
•(3) Subjects with BMI in the range of 18.5 or more and less than 30.0 kg/m2 and body weight 55 kg or more
•(4) Subjects who understand the objectives of the study, volunteer to participate in the study, and are able to provide written informed consent

•(1) Subjects with a medical history of gastrointestinal, skin, renal, hepatic, neurological, hematological, endocrine, cancer, respiratory, immunological, psychological, cardiovascular, or other diseases that is considered to affect safety of the subjects and evaluation of the study drug by the principal investigator or subinvestigator
•(2) Subjects with a history of surgery or a disease condition that is considered by the principal investigator or subinvestigator to affect the distribution, metabolism, and excretion of the study drug
•(3) Subjects who have previously received favipiravir
•(4) Subjects who are deemed to be ineligible for the study by the principal investigator or subinvestigator

发起方

Sakurai Tsutomu