臨床研究等提出・公開システム

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

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

Sato Hirofumi

TMS Co., Ltd.

11F Keio Fuchu 1chome Bldg. 1-9, Fuchucho, Fuchu-shi, Tokyo 183-0055, Japan

satohiro@tms-japan.co.jp

Sato Hirofumi

TMS Co., Ltd.

11F Keio Fuchu 1chome Bldg. 1-9, Fuchucho, Fuchu-shi, Tokyo 183-0055, Japan

+81-42-307-7480

satohiro@tms-japan.co.jp

Recruiting

May. 29, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

basic science

(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.

Male

acute kidney injury

A single intravenous administration of TMS-008 or placebo to healthy adult Japanese males.

(1)Safety : Adverse event, 12-lead electrocardiogram, vital signs, laboratory tests (hematological tests, biochemical tests)
(2)Pharmacokinetics
(3)Biomarkers

April. 23, 2024

No

none