UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and pharmacokinetics of single and repeated dose of intra-nasal TTA-121 in healthy volunteers (Phase 1 trial).
Title of the study (Brief title)	Safety and pharmacokinetics of single and repeated dose of intra-nasal TTA-121 in healthy volunteers (Phase 1 trial).
Region	Japan

Condition
Condition	Autism Spectrum Disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety of single dose (5-200U/ml, 0.1ml/dose) or repeated dose (30-200U/ml, 0.1ml/dose, QD or BID, 9days) intra-nasal TTA-121 in healthy Japanese male volunteers.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	AE vital signs and body weight laboratory data ECG
Key secondary outcomes	plasma concentration of oxytocin PK parameters of TTA-121

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	<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
Interventions/Control_2	<Single dose> Placebo, 0.1mlX1, intra-nasal <Repeated dose> Placebo, 0.1mlx1, QD or BID, 9days
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	35 years-old >
Gender	Male
Key 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
Key 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.
Target sample size	64

Research contact person
Name of lead principal investigator	Chie Sakanaka
Organization	The University of Tokyo Hospital
Division name	Clinical Research Support Center/Phase 1 Unit
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL	03-5800-9513
Email	sakanaka-chie@umin.org

Public contact
Name of contact person	Mai Harasawa
Organization	The University of Tokyo Hospital
Division name	Clinical Research Support Center
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL	03-5800-8743
Homepage URL
Email	mai-harasawa@umin.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京大学医学部附属病院臨床研究支援センター　P1ユニット

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 25 Day
Anticipated trial start date	2017 Year 02 Month 09 Day
Last follow-up date	2017 Year 08 Month 16 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 09 Month 12 Day
Date analysis concluded	2017 Year 10 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 31 Day
Last modified on	2017 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029101