Phase I, Single Dose, Dose Escalation Study of TMS-008 in Healthy Adult Male Subjects

TMS Co., Ltd.0 个研究点目标入组 40 人开始时间: 2024年6月18日最近更新: 2025年3月5日

适应症

试验速览

暂无简介。

•(1) Japanese male aged 18 to 45 years, at the time of signing the informed consent form (ICF).
•(2) BMI (kg/m2) both at the time of screening and on the day before administration of the study drug (Day -1) are in the range of 18.0 or more and less than 25.0, and the body weights are 50 kg or more.
•(3) Vital signs at the time of screening and Day-1 are as follows
•Systolic blood pressure (supine): 90 mmHg to no more than 139 mmHg
•Diastolic blood pressure (supine): 40 mmHg to no more than 89 mmHg

•(1) Either liver or biliary tract function is affected by a past or current history of liver and biliary tract disease, or by surgery such as cholecystectomy or biopsy.
•(2) Histories of serious head or spinal cord trauma/surgery, gastrointestinal or urinary tract bleeding, major surgery, or serious trauma other than head within 3 months prior to the study drug dosing.
•(3) Acute symptoms (nausea, vomiting, infection, fever, diarrhea, etc.) within 7 days prior to the study drug dosing.

Safety

Adverse event, 12-lead electrocardiogram, vital signs, laboratory tests (hematological tests, biochemical tests)

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发起方