Healthy VolunteersPhase 1VRP-034NCT07502144
A Phase I Study Comparing the Safety, Pharmacokinetics and Renal Effects of VRP-034 and Marketed Polymyxin B in Healthy Volunteers
A Phase 1 study testing VRP-034 (Polymyxin B 500,000 IU) and Commercially available Polymyxin B 500,000 IU (Poly-MxB) in people with Healthy Volunteers, run by Venus Remedies Limited at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- VRP-034 (Polymyxin B 500,000 IU) and Commercially available Polymyxin B 500,000 IU (Poly-MxB)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 kg/m2, 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. Further details as mentioned in the approved protocol
Who cannot join
- 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
Show all 9Show fewer
- 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 Further details as mentioned in the approved protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anmol Aggarwal contact
India1 site
Veeda Clinical Research Ltd
Ahmedabad, Gujarat, 380015
Hiren Prajapati, MD (Pharmacology), Hiren.P1891@veedalifesciences.com
About this study
Official title: 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
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.
Read more
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 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.
- Conditions
- Healthy Volunteers
- Being tested
- VRP-034 (Polymyxin B 500,000 IU), Commercially available Polymyxin B 500,000 IU (Poly-MxB)
- Keywords
- VRP-034, Polymyxin B, PMB, supramolecular cationic formulation, nephrotoxicity, kidney injury biomarkers, novel urinary kidney injury biomarkers, polymyxin b-associated kidney injury, Acute kidney injury, Renal Guard Programme, NAG, NGAL, KIM-1, Cystatin C, Osteopontin, Clusterin, ELISA
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRP-034 (Polymyxin B 500,000 IU)Drug
VRP-034 (Novel formulation of polymyxin B 500,000 IU) of Venus Remedies Limited
Commercially available Polymyxin B 500,000 IU (Poly-MxB)Drug
Commercially available Polymyxin B 500,000 IU (Poly-MxB)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | VRP-034 (Novel formulation of Polymyxin B 500,000 IU) of Venus Remedies Limited and Poly-MxB (Marketed Polymyxin B 500,000 IU) dose of 0.4 mg per kg in first SAD Cohort, total 6 subjects (3 subjects to receive either VRP-034 or Poly-MxB), 1.5 hours IV infusion. Receives: Drug: VRP-034 (Polymyxin B 500,000 IU); Drug: Commercially available Polymyxin B 500,000 IU (Poly-MxB) |
| Cohort 2 | Experimental | VRP-034 (Novel formulation of Polymyxin B 500,000 IU) of Venus Remedies Limited and Poly-MxB (Marketed Polymyxin B 500,000 IU) dose of 0.75 mg per kg in first SAD Cohort, total 6 subjects (3 subjects to receive either VRP-034 or Poly-MxB), 1.5 hours IV infusion. Receives: Drug: VRP-034 (Polymyxin B 500,000 IU); Drug: Commercially available Polymyxin B 500,000 IU (Poly-MxB) |
| Cohort 3 | Experimental | VRP-034 (Novel formulation of Polymyxin B 500,000 IU) of Venus Remedies Limited and Poly-MxB (Marketed Polymyxin B 500,000 IU) dose of 1.5 mg per kg in first SAD Cohort, total 6 subjects (3 subjects to receive either VRP-034 or Poly-MxB), 3 hours IV infusion. Receives: Drug: VRP-034 (Polymyxin B 500,000 IU); Drug: Commercially available Polymyxin B 500,000 IU (Poly-MxB) |
| Cohort 4 | Experimental | VRP-034 (Novel formulation of Polymyxin B 500,000 IU) of Venus Remedies Limited and Poly-MxB (Marketed Polymyxin B 500,000 IU) doses of 1.5 mg per kg in fourth Multidose Cohort (12 hourly two days dosing, total four doses), total 18-30 subjects (9 -15 subjects to receive either VRP-034 or Poly-MxB), 3 hours IV infusion. Receives: Drug: VRP-034 (Polymyxin B 500,000 IU); Drug: Commercially available Polymyxin B 500,000 IU (Poly-MxB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean of Fold Changes From Baseline in Six Urinary Kidney Injury Biomarkers (CLU, CysC, KIM-1, NAG, NGAL, OPN), Each Normalized to Urine Creatinine (Composite Measure)
The composite measure (CM) is calculated for each subject as the geometric mean of fold changes from baseline in six urinary biomarkers: Clusterin (CLU), Cystatin-C (CysC), Kidney Injury Molecule-1 (KIM-1), N-acetyl-β-D-glucosaminidase (NAG), Neutrophil Gelatinase-Associated Lipocalin (NGAL), and Osteopontin (OPN). Each biomarker is normalized to urine creatinine prior to analysis. Fold change is defined as the ratio of post-dose to pre-dose normalized values. The CM is calculated as the exponential of the arithmetic mean of natural log-transformed fold changes. A CM value of 1.0 indicates no change from baseline, while higher values indicate increased nephrotoxicity and lower values indicate reduced nephrotoxicity.
The natural log-transformed CM (ln[CM]) will be compared between treatment groups using an analysis of variance (ANOVA) model.
Measured: 48 hours after first dose (multiple-dose cohort); 24 hours after dosing (SAD cohorts 2 and 3)
Secondary outcomes (10)
Geometric Mean of Fold Changes From Baseline in Six Urinary Kidney Injury Biomarkers (CLU, CysC, KIM-1, NAG, NGAL, OPN), Each Normalized to Urine Creatinine (Composite Measure)
The composite measure (CM) is calculated for each subject as the geometric mean of fold changes from baseline in six urinary biomarkers: Clusterin (CLU), Cystatin-C (CysC), Kidney Injury Molecule-1 (KIM-1), N-acetyl-β-D-glucosaminidase (NAG), Neutrophil Gelatinase-Associated Lipocalin (NGAL), and Osteopontin (OPN). Each biomarker is normalized to urine creatinine prior to analysis. Fold change is defined as the ratio of post-dose to pre-dose normalized values. The CM is calculated as the exponential of the arithmetic mean of natural log-transformed fold changes. A CM value of 1.0 indicates no change from baseline, while higher values indicate increased nephrotoxicity and lower values indicate reduced nephrotoxicity.
The natural log-transformed CM (ln[CM]) will be compared between treatment groups using an analysis of variance (ANOVA) model.
Measured: 24 hours after first dose (multiple-dose cohort); 48 hours after dosing (SAD cohorts 2 and 3)
Maximum plasma concentration (Cmax) of polymyxin B
Cmax will be derived from plasma concentration-time data using non-compartmental analysis and summarized by treatment group.
Measured: SAD cohorts: up to 48 hours post-dose; multiple-dose cohort: up to 12 hrs after first dose and up to 48 hrs after fourth dose.
Area under the plasma concentration-time curve (AUC0-t) of polymyxin B
AUC0-t will be calculated using non-compartmental methods, and summarized by treatment group.
Measured: SAD cohorts: up to 48 hours post-dose; multiple-dose cohort: up to 12 hours post first dose and up 48 hrs post fourth dose
Number of participants with acute kidney injury (AKI) based on RIFLE criteria
AKI will be assessed using serum creatinine changes from baseline and classified according to RIFLE criteria (Risk, Injury, Failure). Incidence will be summarized by treatment group.
Measured: Baseline (pre-dose), Day 1, Day 2, Day 7, Day 14
Change from baseline in serum creatinine
Serum creatinine values will be measured and summarized as change from baseline by treatment group and time point.
Measured: Baseline (pre-dose), Day 1, Day 2, Day 7, Day 14
Change from baseline in blood urea nitrogen (BUN)
BUN values will be measured and summarized as change from baseline by treatment group and time point.
Measured: Baseline (pre-dose), Day 1, Day 2, Day 7, Day 14
Change from baseline in urinary creatinine
Urinary creatinine levels will be measured and summarized as change from baseline by treatment group and time point.
Measured: Baseline (pre-dose), Day 1, Day 2, Day 7, Day 14
Change from baseline in urinary albumin
Urinary albumin levels will be measured and summarized as change from baseline by treatment group and time point.
Measured: Baseline (pre-dose), Day 1, Day 2, Day 7, Day 14
Change from baseline in urine total protein
Urine total protein will be measured and summarized as change from baseline by treatment group and time point.
Measured: Baseline (pre-dose), Day 1, Day 2, Day 7, Day 14
Number of participants with treatment-emergent adverse events (TEAEs)
Treatment-emergent adverse events (TEAEs) are defined as any adverse event occurring or worsening after administration of study drug. TEAEs will be summarized by treatment group, severity (CTCAE v5.0), and relationship to study drug.
Measured: From first dose up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venus Remedies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hiren Prajapati, MD Pharmacology, Principal investigator, Veeda Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502144
- Sponsor's protocol ID
- 23-VIN-0367
- Other IDs
- CTRI/2026/02/104919
- Acronym
- VRP-034
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vishwakarma K, Bisht A, Kumar P, Kumar S, Akhter J, Payasi A, Chaudhary S, Aggarwal A. Toxicokinetic profiling of VRP-034: Evaluating its potential in mitigating polymyxin-B-associated nephrotoxicity. Int J Antimicrob Agents. 2025 Feb;65(2):107393. doi: 10.1016/j.ijantimicag.2024.107393. Epub 2024 Nov 28.
PubMed 39612992Payasi A, Yadav MK, Chaudhary S, Aggarwal A. Evaluating nephrotoxicity reduction in a novel polymyxin B formulation: insights from a 3D kidney-on-a-chip model. Antimicrob Agents Chemother. 2024 Oct 8;68(10):e0021924. doi: 10.1128/aac.00219-24. Epub 2024 Sep 3.
PubMed 39225483Pye K, Tasinato E, Shuttleworth S, Devlin C, Brown C. Comparison of the Impact of VRP-034 and Polymyxin B upon Markers of Kidney Injury in Human Proximal Tubule Monolayers In Vitro. Antibiotics (Basel). 2024 Jun 6;13(6):530. doi: 10.3390/antibiotics13060530.
PubMed 38927196
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07502144
- Acronym / sponsor ID
- VRP-034 / 23-VIN-0367
- Conditions
- Healthy Volunteers
- Keywords
- VRP-034, Polymyxin B, PMB, supramolecular cationic formulation, nephrotoxicity, kidney injury biomarkers, novel urinary kidney injury biomarkers, polymyxin b-associated kidney injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Venus Remedies LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: VRP-034 (Polymyxin B 500,000 IU), Drug: Commercially available Polymyxin B 500,000 IU (Poly-MxB)VRP-034 (Novel formulation of Polymyxin B 500,000 IU) of Venus Remedies Limited and Poly-MxB (Marketed Polymyxin B 500,000 IU) dose of 0.4 mg per kg in first SAD Cohort, total 6 subjects (3 subjects to receive either VRP-034 or Poly-MxB), 1.5 hours IV infusion. |
| Cohort 2 | Experimental | Drug: VRP-034 (Polymyxin B 500,000 IU), Drug: Commercially available Polymyxin B 500,000 IU (Poly-MxB)VRP-034 (Novel formulation of Polymyxin B 500,000 IU) of Venus Remedies Limited and Poly-MxB (Marketed Polymyxin B 500,000 IU) dose of 0.75 mg per kg in first SAD Cohort, total 6 subjects (3 subjects to receive either VRP-034 or Poly-MxB), 1.5 hours IV infusion. |
| Cohort 3 | Experimental | Drug: VRP-034 (Polymyxin B 500,000 IU), Drug: Commercially available Polymyxin B 500,000 IU (Poly-MxB)VRP-034 (Novel formulation of Polymyxin B 500,000 IU) of Venus Remedies Limited and Poly-MxB (Marketed Polymyxin B 500,000 IU) dose of 1.5 mg per kg in first SAD Cohort, total 6 subjects (3 subjects to receive either VRP-034 or Poly-MxB), 3 hours IV infusion. |
| Cohort 4 | Experimental | Drug: VRP-034 (Polymyxin B 500,000 IU), Drug: Commercially available Polymyxin B 500,000 IU (Poly-MxB)VRP-034 (Novel formulation of Polymyxin B 500,000 IU) of Venus Remedies Limited and Poly-MxB (Marketed Polymyxin B 500,000 IU) doses of 1.5 mg per kg in fourth Multidose Cohort (12 hourly two days dosing, total four doses), total 18-30 subjects (9 -15 subjects to receive either VRP-034 or Poly-MxB), 3 hours IV infusion. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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 kg/m2, 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRP-034 (Polymyxin B 500,000 IU)VRP-034 (Novel formulation of polymyxin B 500,000 IU) of Venus Remedies Limited | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| Commercially available Polymyxin B 500,000 IU (Poly-MxB)Commercially available Polymyxin B 500,000 IU (Poly-MxB) | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Geometric Mean of Fold Changes From Baseline in Six Urinary Kidney Injury Biomarkers (CLU, CysC, KIM-1, NAG, NGAL, OPN), Each Normalized to Urine Creatinine (Composite Measure)
Time frame: 48 hours after first dose (multiple-dose cohort); 24 hours after dosing (SAD cohorts 2 and 3)
The composite measure (CM) is calculated for each subject as the geometric mean of fold changes from baseline in six urinary biomarkers: Clusterin (CLU), Cystatin-C (CysC), Kidney Injury Molecule-1 (KIM-1), N-acetyl-β-D-glucosaminidase (NAG), Neutrophil Gelatinase-Associated Lipocalin (NGAL), and Osteopontin (OPN). Each biomarker is normalized to urine creatinine prior to analysis. Fold change is defined as the ratio of post-dose to pre-dose normalized values. The CM is calculated as the exponential of the arithmetic mean of natural log-transformed fold changes. A CM value of 1.0 indicates no change from baseline, while higher values indicate increased nephrotoxicity and lower values indicate reduced nephrotoxicity. The natural log-transformed CM (ln[CM]) will be compared between treatment groups using an analysis of variance (ANOVA) model.
10 secondary outcomes
Geometric Mean of Fold Changes From Baseline in Six Urinary Kidney Injury Biomarkers (CLU, CysC, KIM-1, NAG, NGAL, OPN), Each Normalized to Urine Creatinine (Composite Measure)
Time frame: 24 hours after first dose (multiple-dose cohort); 48 hours after dosing (SAD cohorts 2 and 3)
Maximum plasma concentration (Cmax) of polymyxin B
Time frame: SAD cohorts: up to 48 hours post-dose; multiple-dose cohort: up to 12 hrs after first dose and up to 48 hrs after fourth dose.
Area under the plasma concentration-time curve (AUC0-t) of polymyxin B
Time frame: SAD cohorts: up to 48 hours post-dose; multiple-dose cohort: up to 12 hours post first dose and up 48 hrs post fourth dose
Number of participants with acute kidney injury (AKI) based on RIFLE criteria
Time frame: Baseline (pre-dose), Day 1, Day 2, Day 7, Day 14
Change from baseline in serum creatinine
Time frame: Baseline (pre-dose), Day 1, Day 2, Day 7, Day 14
Change from baseline in blood urea nitrogen (BUN)
Time frame: Baseline (pre-dose), Day 1, Day 2, Day 7, Day 14
Change from baseline in urinary creatinine
Time frame: Baseline (pre-dose), Day 1, Day 2, Day 7, Day 14
Change from baseline in urinary albumin
Time frame: Baseline (pre-dose), Day 1, Day 2, Day 7, Day 14
Change from baseline in urine total protein
Time frame: Baseline (pre-dose), Day 1, Day 2, Day 7, Day 14
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: From first dose up to Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 39612992Vishwakarma K, Bisht A, Kumar P, Kumar S, Akhter J, Payasi A, Chaudhary S, Aggarwal A. Toxicokinetic profiling of VRP-034: Evaluating its potential in mitigating polymyxin-B-associated nephrotoxicity. Int J Antimicrob Agents. 2025 Feb;65(2):107393. doi: 10.1016/j.ijantimicag.2024.107393. Epub 2024 Nov 28.
- Background: PubMed 39225483Payasi A, Yadav MK, Chaudhary S, Aggarwal A. Evaluating nephrotoxicity reduction in a novel polymyxin B formulation: insights from a 3D kidney-on-a-chip model. Antimicrob Agents Chemother. 2024 Oct 8;68(10):e0021924. doi: 10.1128/aac.00219-24. Epub 2024 Sep 3.
- Background: PubMed 38927196Pye K, Tasinato E, Shuttleworth S, Devlin C, Brown C. Comparison of the Impact of VRP-034 and Polymyxin B upon Markers of Kidney Injury in Human Proximal Tubule Monolayers In Vitro. Antibiotics (Basel). 2024 Jun 6;13(6):530. doi: 10.3390/antibiotics13060530.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anmol Aggarwal contact
Hiren Prajapati, MD Pharmacology principal investigator
Veeda Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VRP-034 (Polymyxin B 500,000 IU) and Commercially available Polymyxin B 500,000 IU (Poly-MxB) in people with Healthy Volunteers, run by Venus Remedies Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sumit Saxena (91-9875910291, pv_hod@venusremedies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean of Fold Changes From Baseline in Six Urinary Kidney Injury Biomarkers (CLU, CysC, KIM-1, NAG, NGAL, OPN), Each Normalized to Urine Creatinine (Composite Measure) (time frame: 48 hours after first dose (multiple-dose cohort); 24 hours after dosing (SAD cohorts 2 and 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07502144, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.