FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/02/104919 [Registered on: 26/02/2026] Trial Registered Prospectively
Last Modified On: 27/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  		 A clinical study to compare the safety of VRP-034 (A Novel Formulation of Polymyxin B) against commercially available polymyxin B medicine, and their effects on the kidney. 
Scientific Title of Study   A Single center, prospective, double-blind, balanced, randomized, two-treatment, single-period, single ascending dose (SAD) and multiple-dose, parallel, Phase I, study to compare the safety, tolerability and pharmacokinetics of Test formulation VRP-034 (novel formulation of polymyxin B 500,000 IU) of Venus Remedies Limited vs commercially available polymyxin B for Injection USP (Poly-MxB) 500,000 IU in normal healthy adult male human subjects. 
Trial Acronym  VRP-034 
Secondary IDs if Any  
Secondary ID  Identifier 
23-VIN-0367 Version 3.0 Dated 10 Feb 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hiren Prajapati 
Designation  Principal Investigator, MD Pharmacology 
Affiliation  Veeda Clinical Research Ltd 
Address  Veeda Clinical Research Ltd 2nd, 3rd & 4th Floor, Shivalik Plaza A, Near I.I.M., Ambawadi, Ahmedabad 380015,India

Ahmadabad
GUJARAT
380015
India 
Phone  7967773000  
Fax    
Email  Hiren.P1891@veedalifesciences.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sumit Saxena 
Designation  General Manager 
Affiliation  Venus Remedies Limited 
Address  Corporate Office 51&52, Industrial Area, Phase 1, Panchkula, Haryana, 134114, India

Panchkula
HARYANA
134114
India 
Phone  9875910291  
Fax    
Email  pv_hod@venusremedies.com  
 
Details of Contact Person
Public Query  
Name  Dr Sumit Saxena 
Designation  General Manager 
Affiliation  Venus Remedies Limited 
Address  Corporate Office 51&52, Industrial Area, Phase 1, Panchkula, Haryana, 134114, India

Panchkula
HARYANA
134114
India 
Phone  9875910291  
Fax    
Email  pv_hod@venusremedies.com  
 
Source of Monetary or Material Support  
Venus Remedies Limited Hill Top Industrial Estate Near Jharmajri, E.P.I.P., Phase-I, (Extention) Village Bhatoli Kalan Baddi, Himachal Pradesh Pin code: 173 205, India  
 
Primary Sponsor  
Name  Venus Remedies Limited 
Address  Venus Remedies Limited Jharmajri, Hill top Industrial Estate, EPIP, Phase 1 Extn, Bhatoli kalan, Baddi, Solan Himachal Pradesh 173205, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hiren Prajapati  Veeda Clinical Research Ltd  2nd, 3rd & 4th Floor, Shivalik Plaza-A, Near I.I.M., Ambawadi, Ahmedabad – 380 015, India
Ahmadabad
GUJARAT 		 7967773000

Hiren.P1891@veedalifesciences.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SANGINI HOSPITAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Poly-MxB  Polymyxin B for Injection USP 500,000 IU, Poly-MxB of Bharat Serums and Vaccines Limited (Commercially available). 
Intervention  VRP-034  Novel formulation of polymyxin B 500,000 IU of Venus Remedies Limited. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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.  For SAD 2 and 3 at 24 hrs,
For Multidose at 48 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the nephrotoxicity associated with VRP-034 vs commercially available polymyxin B using a composite measure of early kidney injury urinary biomarkers  For SAD at 48 hrs
For Multidose at 24 hrs 
To monitor the safety and tolerability of subjects  Throughout study 
To assess the pharmacokinetics of polymyxin B for PK parameters  Cmax and AUC0-t. 
Assess the incidence of Acute kidney injury (AKI) and severity of renal damage (using RIFLE criteria by considering serum creatinine)  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)  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 first   Pre-dose and on days 1, 2, 7 and 14 days 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   27/05/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
This is a Phase 1, single-center, randomized, double-blind, active-controlled clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and nephrotoxicity attenuation potential of VRP-034 compared with commercially available polymyxin B in healthy adult male volunteers. 
VRP-034 is a supramolecular cationic formulation of polymyxin B developed with the objective of mitigating polymyxin B–associated nephrotoxicity while preserving its established antibacterial activity against MDR Gram-negative pathogens. Although polymyxin B remains an important last-line therapy for serious infections caused by carbapenem-resistant organisms, its clinical use is limited by dose-dependent renal toxicity. VRP-034 has been developed with a strategy aimed at reducing kidney injury without compromising antimicrobial exposure, and preclinical studies have demonstrated an improved renal safety profile compared with conventional formulations. 
This study consists of three single ascending dose (SAD) cohorts followed by one multiple-dose cohort. In the SAD phase, subjects will receive weight-based intravenous equivalent doses of polymyxin B (0.4 mg/kg, 0.75 mg/kg, and 1.5 mg/kg) administered over specified infusion durations. The multiple-dose cohort will receive 1.5 mg/kg every 12 hours for up to 2 days. An independent Data Safety Monitoring Board (DSMB) will review safety and pharmacokinetic data after each SAD cohort prior to dose escalation and before initiation of the multiple-dose cohort. 
The primary objective is to assess the effect of VRP-034 on polymyxin B–associated nephrotoxicity using a composite measure of novel urinary kidney injury biomarkers (qualified by US FDA). Secondary objectives include assessment of safety, tolerability, and pharmacokinetic parameters.
 
Close