UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018252 |
|---|---|
| Receipt number | R000021120 |
| Scientific Title | Evaluation of safety and tolerability of mesenchymal stem cell mobilization factor KOI2 (Phase 1 study ) |
| Date of disclosure of the study information | 2015/07/16 |
| Last modified on | 2017/04/13 19:13:32 |
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Basic information
Public title
Evaluation of safety and tolerability of mesenchymal stem cell mobilization factor KOI2 (Phase 1 study )
Acronym
Evaluation of safety and tolerability of mesenchymal stem cell mobilization factor KOI2 (Phase 1 study )
Scientific Title
Evaluation of safety and tolerability of mesenchymal stem cell mobilization factor KOI2 (Phase 1 study )
Scientific Title:Acronym
Evaluation of safety and tolerability of mesenchymal stem cell mobilization factor KOI2 (Phase 1 study )
Region
| Japan |
Condition
Condition
Epidermolysis bullosa
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and tolerability in healthy volunteer subjects
Basic objectives2
Others
Basic objectives -Others
Safety,Tolerability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety(Adverse events, medical examination, 12-lead electrocardiogram, vital signs and laboratory data)
Key secondary outcomes
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
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group1
KOI2 0.15mg/kg or Placebo, single dose administration
Interventions/Control_2
Group2
KOI2 0.5mg/kg or Placebo, single dose administration
Interventions/Control_3
Group3
KOI2 1.5mg/kg or Placebo, single dose administration
Interventions/Control_4
Group4
KOI2 5.0mg/kg or Placebo, single dose administration
Interventions/Control_5
Group5
KOI2 (1.5mg/kg or 3.0mg/kg) or Placebo in multiple dose administration for 4 days
Interventions/Control_6
Group6
KOI2 3.0mg/kg or Placebo, single dose administration
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1) Healthy Japanese male age >=20 years and<= 40 years old
2) BMI (kg/m2) more than 18.0 and less than 25.0
BMI = weight [kg] / (height [m]) 2
3) A subject who hans not been smoking form more than 1 year and can agree to stop smoking from the day before the first dosage adminiatraion through post administration clinical visits
4) A subject who agrees to not consume alcohol 24 hours before hospitalization till discharge and 24 hours prior to every post clinical visits
5) A subject who agrees to prevent pregnacy until 28 days post the last dosage administration
Key exclusion criteria
1) A subject who has liver, kidney, GI, respiratory, heart and a blood system disease
2) A subject who has a past histroy of drug dependency
3) A subject who is difficult for intravenous administration (including episodes of vagal reflex syncope)
4) A subject who has the past of clinically significant drug allergy symptom and allergy to vaccine( eanaphylactic shock, severe food allergy, hives, recurrent dermatitis, drug hypersensitivity, allergy to protein preparation, vascular edema)
5) A subject who has clinically important abnormal laboratory data by a blood test or urine test at the time of screening
6) A subject who is HIV Ab, HBs Ag, or HCV Ab positive by screening examination
7) Screening or baseline Qtc is over 450 msec or QRS interval is over 120 msec by 12-lead electrocardiogram
8) Screening or baseline BP is over 140/90 mmHg or below 100/50, or HR is out of the range of 40-100 after 5 minutes rest
9) A subject who has fever(body temperature over 37 degrees Celsius)
10) A subject who participated in other clinical trials within four months and received a clinical trial drug (including a placebo)
11) A subject using prescribed drug and/or Over-The-Counter drugs within 14 days
12) The person who lost more than 400 mL blood within 12 weeks or 200 ml blood within 4 weeks(by blood donation, etc.)
13) Ineligible by other reasons judged by the investigators
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuto Tamai |
Organization
Osaka University Hospital
Division name
Dermatology
Zip code
Address
2-15, Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL
06-6879-3902
tamai@gts.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuto Tamai |
Organization
Osaka University Hospital
Division name
Dermatology
Zip code
Address
2-15, Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL
06-6879-3902
Homepage URL
tamai@gts.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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 | 16 | 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 | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 20 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 07 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 09 | Day |
Last modified on
| 2017 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021120
