Phase1 clinical study of a single intravenous dose of TRM-1106 in healthy Japanese adult me

Not Applicable

• Conditions: Healthy male subjects

• Registration Number: JPRN-UMIN000005914
• Lead Sponsor: Terumo Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1) Subject who has been tested positive in a urine drug test or has a history of drug abuse. 2) Subject who has been tested positive for HBs antigen, HCV antibody or HIV antibody, or who has a positive serological test for syphilis. 3) Subject who has a history of hypersensitivity or allergy to the study drug (active component and additives) 4) Subject who currently has or has a history of peptic ulcer; or subject who currently has or has a history of asthma. 5) Subject with clinically significant disease related to the heart, liver, kidneys, respiratory system, gastrointestinal system, endocrine system, immune system, skin, blood, or psychiatric/nervous system. 6) Subject who has liver function test values (T-Bil/D-Bil, ALT (GPT), AST (GOT), gamma-GTP and ALP) that exceed the facility's upper limit. However, if the investigator deems that the reason for exceeding the limit is not due to the liver, the subject may be enrolled. 7) Subject who currently has or have a history of clinically significant bleeding or bleeding tendency. 8) Subject who has taken other medication or supplements within 1 week prior to study drug administration. 9) Subject who need to take other medication concurrently while participating in this study. 10) Subject who smoked tobacco within 1 month prior to study drug administration. 11) Subject who habitually consume a large amount of alcohol (ingestion of >=60 g per day as pure alcohol), or have ingested alcohol within 3 days prior to study drug administration. 12) Subject who has ingested food products containing St. John's wort within 2 weeks prior to study drug administration. 13) Subjects who has ingested grapefruit or processed grapefruit products within 1 week prior to study drug administration.

Study & Design

• Study Type: Interventional
• Study Design: Not specified