Safety and pharmacokinetics of single and repeated dose of intra-nasal TTA-121 in healthy volunteers (Phase 1 trial).
Phase 1
- Conditions
- Autism Spectrum Disorder
- Registration Number
- JPRN-UMIN000025922
- Lead Sponsor
- The University of Tokyo Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 64
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AE vital signs and body weight laboratory data ECG
- Secondary Outcome Measures
Name Time Method plasma concentration of oxytocin PK parameters of TTA-121