Healthy volunteers(The planned indication has not been determined.)
Conditions
Interventions
1) Part A:Subjects receive single intravenous administration of ONO-SE-853(18F).
2) Part B:In the period1, subjects receive single intravenous administration of ONO-SE-853(18F). In the period2, subjec
Sponsors
Hirashima Yoshinori
Eligibility
Inclusion criteria
Inclusion criteria: 1) Japanese healthy adult male subjects 2) Age at the time of informed consent: 18 to 45 3) BMI (at screening): 18.5 kg/m2 to less than 30.0 kg/m2
Exclusion criteria
Exclusion criteria: 1) Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease. 2) Subjects with current or with a history of severe allergy to drugs or foods 3) Subjects with current or with a history of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Molecule Occupancy in the Brain of ONO-1110 after single oral dose of ONO-1110 in Healthy Adult Males. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Safety, biodistribution and dosimetry of ONO-SE-853(18F) 2)Evaluation of Brain-targeting potential of ONO-SE-853(18F) 3)Evaluation of the relationship between plasma ONO-1110 concentration or ONO-1110 dose and target molecule occupancy of ONO-1110 in the brain 4)Safety of ONO-1110 5)Plasma ONO-1110 Concentrations | — |
Contacts
Public ContactCenter Medical
Ono Pharmaceutical Co.,LTD
Outcome results
None listed