UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018146 |
|---|---|
| Receipt number | R000021014 |
| Scientific Title | Phase I study of transcutaneous adjuvant in healthy volunteers |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2016/07/01 10:08:40 |
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Basic information
Public title
Phase I study of transcutaneous adjuvant in healthy volunteers
Acronym
Phase I study of transcutaneous adjuvant
Scientific Title
Phase I study of transcutaneous adjuvant in healthy volunteers
Scientific Title:Acronym
Phase I study of transcutaneous adjuvant
Region
| Japan |
Condition
Condition
Malignancy
Others
Classification by specialty
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of a new transcutaneous adjuvant
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Safety
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Band-aid with test drug is adhered on the arm for 6h. After detach the band-aid, local skin reaction and systematic adverse events are evaluated.
Interventions/Control_2
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
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
The subjects must satisfy the following conditions.
1) Healthy male at the age of 20 to 65.
2) Subject who provides the written consent.
Key exclusion criteria
The following subjects must be excluded:
1) Subjects under any medical treatment or with diseases requiring medical treatment.
2) Subjects with the past history of severe diseases (diabetes, liver disease, kidney disease, heart disease).
3) Subject with the past history of severe allergic reactions, such as atopic dermatitis, except for those with weak reactions.
4) Subjects with hypersensitivity to adhesive tape.
5)Subject who are judged inappropriate for the trial enrollment based on the results of prior laboratory tests.
6) Subjects who are judged inappropriate for the clinical trial by doctors.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Yamada |
Organization
Kurume University
Division name
Cancer Vaccine Development Division, Research Center for Innovative Cancer Therapy
Zip code
Address
Asahi-machi 67, Kurume, Fukuoka 830-0011
TEL
0942-31-7744
akiymd@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yamada |
Organization
Kurume University
Division name
Cancer Vaccine Development Division, Research Center for Innovative Cancer Therapy
Zip code
Address
Asahi-machi 67, Kurume, Fukuoka 830-0011
TEL
0942-31-7744
Homepage URL
akiymd@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Hisamitsu Pharmaceutical Co.,Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 01 | Day |
Last modified on
| 2016 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021014
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
