acute kidney injury
Conditions
Interventions
A single intravenous administration of TMS-008 or placebo to healthy adult Japanese males.
Sponsors
Sato Hirofumi
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (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
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1)Safety : Adverse event, 12-lead electrocardiogram, vital signs, laboratory tests (hematological tests, biochemical tests) (2)Pharmacokinetics (3)Biomarkers | — |
Contacts
Public ContactHirofumi Sato
TMS Co., Ltd.
Outcome results
None listed