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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018252
Receipt No. 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

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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
Email 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
Email tamai@gts.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021120

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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