A Single Ascending Dose Study of DSP-0378 in Healthy Japanese Adult Male Subjects

Ishikawa Tatsuya0 个研究点目标入组 88 人开始时间: 2022年11月7日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Healthy Japanese adult male subject between 20 and 50 years of age (inclusive) at time of informed consent.
•2. Subject's body weight is between 50.0 kg and 80.0 kg, and body mass index (BMI) is at least 18 kg/m2 but no more than 25 kg/m2.

•1. Subject with a history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, hematological, respiratory, psychiatric, neurologic disease, and who considered ineligible for the study by the Principal Investigator or Sub-Investigator.
•2. Subject who has a presence or history of any medically diagnosed psychiatric disorder (including
•intellectual disability and substance-related disorders).
•3. Subject who answers ''yes'' to ''Suicidal Ideation'' Items 4 or 5 on the Columbia-Suicide Severity
•Rating Scale (C-SSRS) at clinic admission.
•4. Subject with a history of substance abuse, drug abuse, or a positive urine drug screening at screening
•visit or clinic admission.
•5. Subject who has clinical symptoms suggestive of infection with a positive severe acute respiratory
•syndrome coronavirus 2 (SARS-CoV-2), or has a positive SARS-CoV-2 nucleic acid amplification
•test at clinic admission.
•6. Subject who has received a vaccine within 7 days prior to screening visit or clinic admission.
•7. Subject who is in the opinion of the Principal Investigator or Sub-Investigator, unsuitable in any other
•way to participate in this study.

发起方

Ishikawa Tatsuya