None listed
Conditions
Interventions
Drug : Only healthy volunteers undergo screening assessment to determine their eligibility for enrollment into the study from -28 to -1 day (-28d~-1d) before the first administration day (1d). At -1 d
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Subject who voluntarily agree with participation and sign informed consent approved by IRB, after a listened explanation about this clinical trial before the screening test 2) Healthy male between 19 and 45 years of age at the time screening tested 3) Bodyweight between 55 and 90 kg, and BMI between 18.0-27.0 kg/m^2 ? BMI = (weight [kg])/(height [m])^2 4) Subject who is determined to participate by a protocol by physical exam, clinical laboratory test, inquiry, and others, i.e., Subject who has no congenital or chronic disorders and symptoms or manifestations by internal medical examination
Exclusion criteria
Exclusion criteria: 1) History of hepatic, gastrointestinal, circulatory, renal, respiratory, endocrine, neurologic, immunologic, hematologic, psychiatric system, and neoplasm 2) History or clinical evidence of drug abuse 3) History or ongoing of significant allergy of prescription or over-the-counter medication 4) History of hypersensitivity against the investigational product, polymixin B or Colistin 5) Taking any prescription or traditional medication within 2 weeks or over-the-counter medication within 1 week before first investigational drug (IP) administration (but, in the investigator's judgment, when other conditions are suitable, the subject can participate in this trial.) 6) Participation in other clinical trials within 6 months before first IP administration (previous clinical trial's end date is the last administration day) 7) Before first IP administration, whole blood donation within 2 months, apheresis blood donation within 1 month, or blood transfusion within 1 month 8) Smoker over 10 cigarettes per day for 3 months before the first IP administration or who unable to quit smoking from 3 days ago before the first IP administration to last visit 9) Positive result on serology tests (for HBs antigen, HCV antibody, and HIV antibody) 10) Subject who meets any of the following criteria at screening test ? At the vital sign check, systolic blood pressure under 90 mmHg or over 150 mmHg, or diastolic blood pressure under 60 mmHg or over 100 mmHg ? At the electrocardiogram, QTc over 450 msec or manifestation or significant abnormal rhythm ? Renal insufficiency (as evidenced by an estimated eGFR(estimated Glomerular Filtration Rate) < 60 mL/min/1.73m^2 based on the MDRD(Modification of Diet in Renal Disease) formula) ? Hepatic insufficiency (liver enzymes in the blood (AST and ALT) over 1.5 times of upper limit of normal) 11) In the investigator's judgment, subject who has clinical abnormal manifestations of renal function (e.g., severe renal impairment) 12) Contraindications or precautions to investigational product (patients who have myasthenia gravis or porphyria) 13) Subject who refuse to practice acceptable methods of contraception as follows A. Spouse/partner's use of an intrauterine device that proved in failure rate B. Use of spermicide in conjunction with a barrier method(male or female) C. Subject or partner's surgery (vasectomy, salpingectomy/tubal ligation, hysterectomy) 14) Subject who is unable to intake standard meal provided by the clinical trial center 15) Subject who is unable to read the trial contents such as the informed consent form or to understand this trial (e.g., who not able or limited ability to read to informed consent form) 16) Any other factor including laboratory test that, in the investigator's judgment, inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C_max of colistin;C_trough of colistin;AUC_tau of colistin | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma biomarkers of nephrotoxicity;Urinary biomarkers of nephrotoxicity | — |
Countries
Korea, Republic of
Contacts
Public ContactSAEBYUL YOO
Kyung Hee University Hospital
Outcome results
None listed