Septic Acute Kidney Injury
Conditions
Interventions
Group 1: single 1-hour IV infusion of 0.8 mg/kg recAP or placebo
Group 2: single 1-hour IV infusion of 1.6 mg/kg recAP or placebo
Group 3: single 1-hour IV infusion of 3.2 mg/kg recAP or placebo
Group
Sponsors
Meder Wolfgang
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Gender : male 2. Age : 20-55 years, inclusive 3. Body mass index (BMI) : 18.0-30.0 kg/m2, inclusive 4. Subjects must be Japanese by birth, have resided outside Japan <10 years, have parents and maternal and paternal grandparents who are Japanese, and primarily consume a Japanese diet. 5. Resting supine blood pressure at screening showing no clinically relevant deviations from normal as judged by the Principal Investigator. 6. Computerized (12-lead) ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations. 7. All values for hematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Investigator. 8. Ability and willingness to abstain from alcohol and tobacco products from 48 h prior to entry in the clinical research center until discharge. 9. Easily accessible veins for venipuncture and catheter placing. 10. Willingness to sign the written informed consent form (ICF). 11. Subjects must agree to use adequate contraception when sexually active. This applies for the time period between end of first administration and 14 days after the last administration of study drug.
Exclusion criteria
Exclusion criteria: 1. Evidence of clinically relevant pathology. 2. History of relevant drug and/or food allergies. 3. Subject has a history of clinically significant abnormalities or of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study. 4. Use of medication, except for acetaminophen (paracetamol), which is allowed up to 3 days before entry into the clinical research center (after that time the use of a limited amount of acetaminophen is permitted after consultation with the Principal Investigator). 5.Subject is mentally or legally incapacitated, has significant emotional problems at the time of screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last year. 6. Participation in a drug study within 60 days prior to drug administration. 7. Donation of more than 500 mL of blood within 60 days prior to drug administration. Donation of more than 1.5 liters of blood (for men) in the 10 months preceding the start of this study 8. Smoking more than 5 cigarettes, 1 cigar or 1 pipe daily. 9. History of alcohol abuse or drug addiction (including soft drugs like cannabis products). 10. Positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids,barbiturates, benzodiazepines, tricyclic antidepressants) and/or alcohol breath test at Screening and/or Pre-Dose. 11. Intake of more than 14 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine/Japanese Sake or 35 mL of spirits). 12. Positive screen on hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV) or anti-human immunodeficiency virus (anti-HIV)-1 or anti-HIV-2 or HIV-1/2 antigen. 13. Illness within 5 days prior to (the first) drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the pharmacokinetics (PK) of recAP after single and multiple intravenous (IV) doses in healthy Japanese subjects | — |
Contacts
Public ContactTakeshi Kurosawa
CMIC Co., Ltd.
Outcome results
None listed