None listed
Conditions
Interventions
Intervention1: VRP-034: Novel formulation of polymyxin B 500,000 IU of Venus Remedies Limited.
Control Intervention1: Poly-MxB: Polymyxin B for Injection USP 500,000 IU, Poly-MxB of Bharat Serums and
Sponsors
Venus Remedies Limited
Eligibility
Inclusion criteria
Inclusion criteria: Healthy adult male human subjects aged between 18 and 45 years, both inclusive. Subjects weight within normal range according to normal values for Body Mass Index 18.50 to 28.00 kgm2, both inclusive with minimum of 50 kg weight Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable range. Subject with creatinine Clearance greater than and equal to 90 ml per min. Subjects with haemoglobin greater than and equal to 11.5 gm percentage at the time of screening. Subject should be non smoker, non alcoholic. Details mentioned in the approved protocol
Exclusion criteria
Exclusion criteria: Have significant diseases or clinically significant abnormal findings during screening like medical history, physical examination, laboratory evaluations, ECG, and chest X ray. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder. Use of any hormone replacement therapy within three months prior to admission. A depot injection or implant of any drug within three months prior to admission Subjects with G6PD deficiency. Abnormal USG KUB or clinically significant findings in volunteers Difficulty with donating blood. Positive screening test for any one or more i.e HIV, Hepatitis B and Hepatitis C or syphilis RPR. Any other issue which, in the judgment of the Investigator, will make the subject ineligible for study participation Details mentioned in the approved protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the role of VRP-034 in attenuating polymyxin B associated nephrotoxicity compared to commercially available polymyxin B in healthy adult male human subjects using early kidney injury biomarkers after single ascending dose and multiple dose administration.Timepoint: For SAD 2 and 3 at 24 hrs, For Multidose at 48 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the nephrotoxicity associated with VRP-034 vs commercially available polymyxin B using a composite measure of early kidney injury urinary biomarkersTimepoint: For SAD at 48 hrs For Multidose at 24 hrs;To monitor the safety and tolerability of subjectsTimepoint: Throughout study;To assess the pharmacokinetics of polymyxin B for PK parametersTimepoint: Cmax and AUC0-t.;Assess the incidence of Acute kidney injury (AKI) and severity of renal damage (using RIFLE criteria by considering serum creatinine)Timepoint: Pre-dose and on days 1, 2, 7 and 14 days;To assess the change in the traditional kidney injury markers (serum creatinine, Blood urea nitrogen (BUN)Timepoint: Pre-dose and on days 1, 2, 7 and 14 days;To assess the change in the traditional kidney injury markers (urinary creatinine, albumin, and urine total protein/urinary protein) at firstTimepoint: Pre-dose and on days 1, 2, 7 and 14 days | — |
Countries
India
Contacts
Public ContactDr Sumit Saxena
Venus Remedies Limited
Outcome results
None listed