A clinical study to evaluate the pharmacokinetics of colistin and to explore biomarkers for nephrotoxicity in healthy volunteers

Kyung Hee University Hospital0 sites12 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

November 3, 2023

Last Updated

last year

Study Type

Interventional Study

Sex

Male

Sponsor

Kyung Hee University Hospital

•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

•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

Not specified