healthy subjects
Conditions
Interventions
Intravenous administration of PSO17 (single administration, 10% or 20%, 1mL/kg)
Placebo (normal saline)
Sponsors
Hokkaido University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Japanese healthy male (2) BMI 18.5-25.0, Body weight < 60kg (3) age 20-40 (4) agreement of medically appropriate contraception (5) informed consent is obtained after the sufficient explanation of this study
Exclusion criteria
Exclusion criteria: (1) metallic implant (except for conditinally usage devices for MRI scan) , tattoo, or claustrophobia (2) positive MRI findings at pre-observation period (except for doctors aproval) (3) CNS, liver, kidney or heart disease (4) drug allergy (5) long term intake of drugs over 30 days (6) other clinical trials within 90 days (7) significant signs and symptoms (ex. headache, acute infections) within 30 days (8) unexpected values in laboratory tests at pre-observation or preceding period (9) loss of blood (>400 mL) within 12 weeks before the registration, or loss of blood (>200 mL) within 4 weeks before the registration, or blood donation within 2 weeks (10) employees or families of this institute, or who agrees under the compulsion (11) contraindicated for this study due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Evaluation of adverse effect and medically significant change (vital signs) until Day 8 or study suspension 2) laboratory tests (blood tests and urinary tests) at day 2, compared to the baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) blood concentration of H2-17O from imidiate after the administration to Day 8 or study suspension (Cmax, Tmax, AUC, and T1/2) 2) MRI signal change of PSO17 | — |
Countries
Japan
Contacts
Public ContactKohsuke Kudo
Hokkaido University Hospital department of radiology
Outcome results
None listed