JPRN-jRCT2071210042进行中（未招募）1 期
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:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 39age old（—）
- 性别
- Male
入选标准
- •(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
排除标准
- •(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
研究者
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