Autism Spectrum Disorder
Conditions
Interventions
<
Single dose>
TTA-121 (5, 10, 30, 100 or 200U/ml), 0.1mlX1, intra-nasal <
Repeated dose>
TTA-121(30, 100 or 200U/ml), 0.1mlx1, QD or BID, 9days
<
Placebo, 0.1mlX1, intra-nasal <
Placebo, 0.1mlx1, QD or BID, 9days
Sponsors
The University of Tokyo Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) 20~35yrs old, healthy Japanese male 2) Obtained IC 3) BMI 18.5~25 at the time of SCR 4) able to quit smoking from SCR to the follow up date
Exclusion criteria
Exclusion criteria: 1) no history of therapeutic use of oxytocin 2) no history of hypersensitivity of oxytocin 3) no family history of male breast cancer 4) no history or existing condition such as hematological, renal, endocrinological, respiratory, GI tract, cardiovascular, liver, psychological or neurological disease. 5) existing condition which may affect drug absorption, metabolism or secretion. 6) rhinitis or other nasal condition which causes difficulties in intranasal administration. 7) no prior participation and receiving experimental drugs in other clinical trials within 3 months. 8)not suitable to enroll based on medical reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE vital signs and body weight laboratory data ECG | — |
Secondary
| Measure | Time frame |
|---|---|
| plasma concentration of oxytocin PK parameters of TTA-121 | — |
Countries
Japan
Contacts
Public ContactMai Harasawa
The University of Tokyo Hospital Clinical Research Support Center
Outcome results
None listed