Epidermolysis bullosa
Conditions
Interventions
Group1 KOI2 0.15mg/kg or Placebo, single dose administration
Group2 KOI2 0.5mg/kg or Placebo, single dose administration
Group3 KOI2 1.5mg/kg or Placebo, single dose administration
Group4 KO
Sponsors
Osaka University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety(Adverse events, medical examination, 12-lead electrocardiogram, vital signs and laboratory data) | — |
Countries
Japan
Contacts
Public ContactKatsuto Tamai
Osaka University Hospital Dermatology
Outcome results
None listed