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L'essai clinique NCT07502144 (VRP-034) pour Volontaires sains est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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A Phase I Study Comparing the Safety, Pharmacokinetics and Renal Effects of VRP-034 and Marketed Polymyxin B in Healthy Volunteers Phase I 48 Basé sur biomarqueurs Randomisé Double aveugle Escalade de dose
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07502144 (VRP-034) est conçu pour étudier le traitement de Volontaires sains. Il s'agit d'une étude interventionnel en Phase I. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 avril 2026, avec un objectif de 48 participants. Dirigée par Venus Remedies Limited, l'étude devrait être terminée d'ici le 1 décembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 30 mars 2026.
Résumé succinct
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-as...
Afficher plusTitre officiel
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
Pathologies
Volontaires sainsPublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'étude
- VRP-034
- 23-VIN-0367
- CTRI/2026/02/104919 (Identifiant de registre) (Clinical Trials Registry - India)
Numéro NCT
Date de début (réel)
2026-04
Dernière mise à jour publiée
2026-03-30
Date de fin (estimée)
2026-12
Inscription (estimée)
48
Type d'étude
Interventionnel
PHASE
Phase I
Statut
Pas encore en recrutement
Mots clés
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
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
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Double aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalCohort 1 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. | VRP-034 (Polymyxin B 500,000 IU) VRP-034 (Novel formulation of polymyxin B 500,000 IU) of Venus Remedies Limited Commercially available Polymyxin B 500,000 IU (Poly-MxB) Commercially available Polymyxin B 500,000 IU (Poly-MxB) |
ExpérimentalCohort 2 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. | VRP-034 (Polymyxin B 500,000 IU) VRP-034 (Novel formulation of polymyxin B 500,000 IU) of Venus Remedies Limited Commercially available Polymyxin B 500,000 IU (Poly-MxB) Commercially available Polymyxin B 500,000 IU (Poly-MxB) |
ExpérimentalCohort 3 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. | VRP-034 (Polymyxin B 500,000 IU) VRP-034 (Novel formulation of polymyxin B 500,000 IU) of Venus Remedies Limited Commercially available Polymyxin B 500,000 IU (Poly-MxB) Commercially available Polymyxin B 500,000 IU (Poly-MxB) |
ExpérimentalCohort 4 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. | VRP-034 (Polymyxin B 500,000 IU) VRP-034 (Novel formulation of polymyxin B 500,000 IU) of Venus Remedies Limited Commercially available Polymyxin B 500,000 IU (Poly-MxB) Commercially available Polymyxin B 500,000 IU (Poly-MxB) |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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. | 48 hours after first dose (multiple-dose cohort); 24 hours after dosing (SAD cohorts 2 and 3) |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From first dose up to Day 14 |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Homme
Accepte les volontaires en bonne santé
Oui
- 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
- 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 Further details as mentioned in the approved protocol
Venus Remedies LimitedContact central de l'étude
Contact: Sumit Saxena, 91-9875910291, [email protected]
Contact: Anmol Aggarwal, [email protected]
1 Centres de l'étude dans 1 pays
Gujarat
Veeda Clinical Research Ltd, Ahmedabad, Gujarat, 380015, India
Hiren Prajapati, MD (Pharmacology), Contact, [email protected]