Recover of hematogenesis after cord blood transplantation
Conditions
Interventions
step1 TM5509 (120mg, once a day for 3days) washout period more than 3weeks step2 placebo (once a day for 3days)
step1 placebo (once a day for 3days) washout period more than 3weeks step2 TM550
Sponsors
Tohoku university school of medicine, molecular medicine and therapy, Toshio Miyata
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Male Japanese 2.From 20 years old to 45 years old at voluntary written consent 3.From 50.0 kg to 90.0 kg and from 25.0 to 30.0 of BMI at screening 4.More than 20ng/ml of total PAI-1 5.Voluntary written consent by themselves is given before screening.
Exclusion criteria
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.More than grade 1 in liver function disorders 4.Treatment by other doctors (included supplement) within 14 days before screening 5.Treatment with any investigational compound within 120 days before screening 6.History of TM5509 administration 7.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 8.Smoking status and treatment with anti-nicotine agents 9.Known active chronic hepatitis B or C, active syphilis and human immunodeficiency virus infection 10.Abuse of alcohol or drugs (included past history) 11.Bleeding, in the tendency to bleeding, and family history and past history of bleeding disorders 12.Somebody who are directed by principle investigator and employees in Hamamatsu University hospital 13.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamics of TM5509 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Pharmacokinetics of TM5509 | — |
Countries
Japan
Contacts
Public ContactKazuo Umemura
Hamamatsu University Hospital Center for clinical research
Outcome results
None listed