Phase 1 study of TM5509 -placebo controlled single dose study in male healthy adult subjects

Phase 1

• Conditions: Recover of hematogenesis after cord blood transplantation

• Registration Number: JPRN-UMIN000010686
• Lead Sponsor: Tohoku university school of medicine, molecular medicine and therapy, Toshio Miyata

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-17
• Study Completion: 2013-10-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

1.History of liver diseases, cardiovascular diseases, respiratory diseaases, gastroenteric diseases, kidney diseases, cerebralvascular diseases, cancer 2.Known hypersensitivity to some drugs and foods 3.Treatment by other doctors (included supplement) within 14 days before screening 4.Treatment with any investigational compound within 120 days before screening 5.History of TM5509 administration 6.History of blood taken *>= 1200ml of all blood within 1 year before screening *>= 400ml of all blood with 84 days before screening *>= 200ml of all blood within 14 days before screening 7.Smoking status and treatment with anti-nicotine agents 8.Known active chronic hepatitis B or C, active syphilis and human immunodeficiency virus infection 9.Abuse of alcohol or drugs (included past history) 10.Bleeding, in the tendency to bleeding, and family history and past history of bleeding disorders 11.Somebody who are directed by principle investigator and employees in Hamamatsu University hospital 12.Any serious medical or psychiatric illness that could, in the opinion of the investigator, potentially interfere with the completion of treatment according to this protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified