Phase I Clinical Study -Multiple Dose Study of CNT-01

Akita Yasuhiko0 个研究点目标入组 42 人开始时间: 2021年4月14日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Subjects who signed the written informed consent
•2) Age>=20 and =<40 at time of consent
•3) Weight>=45kg, height>=140 cm, and body mass index (BMI) >=18.5 and <25.0 at screening

•1) Subjects with complications such as medically significant gastrointestinal, renal, respiratory, endocrine, hematological, nervous, psychiatric, cardiovascular, or congenital metabolic abnormalities.
•2) Subjects with acute illness within 2 weeks prior to administration of the investigational drug.
•3) Subjects with a current or past history of drug or food allergy.
•4) Subjects with QTcF of 450 msec or more, PR interval of 220 msec or more, or QRS width of 120 msec or more on 12-lead ECG performed before administration on Day 1.
•5) Subjects with a history of syncope.
•6) Subjects with family history of congenital long QT syndrome or sudden cardiac death.
•7) Patients with a history of infection requiring treatment within 4 weeks prior to administration of the investigational drug.
•8) Persons with a positive SARS-CoV-2 test (nucleic acid amplification test) or suspected COVID-19 test performed within 3 days before admission to the hospital.

发起方

Akita Yasuhiko