Phase I, single-dose escalation study of TMS-008 in healthy adult males

JRCT ID: jRCT2031240084

Registered date:14/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: acute kidney injury
• Date of first enrollment: 29/05/2024
• Target sample size: 40
• Study type: Interventional
• Intervention(s): A single intravenous administration of TMS-008 or placebo to healthy adult Japanese males.

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Male

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Sato Hirofumi