UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of safety and tolerability of mesenchymal stem cell mobilization factor KOI2 (Phase 1 study )
Title of the study (Brief title)	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	Katsuto Tamai
Organization	Osaka University Hospital
Division name	Dermatology
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	Katsuto Tamai
Organization	Osaka University Hospital
Division name	Dermatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 06 Day
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

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Publication of results	Unpublished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