Trial Radar IA | ||
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Lo studio clinico NCT07502144 (VRP-034) per Volontari sani è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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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 Fase I 48 Basato su biomarcatori Randomizzato Doppio cieco Escalation della dose
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La sperimentazione clinica NCT07502144 (VRP-034) è uno studio interventistico di Fase I volto a esaminare il trattamento per Volontari sani, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 aprile 2026, con l'obiettivo di raggiungere 48 partecipanti. Sotto la guida di Venus Remedies Limited, dovrebbe concludersi entro il 1 dicembre 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 30 marzo 2026.
Sommario breve
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...
Mostra di piùTitolo ufficiale
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
Patologie
Volontari saniPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- VRP-034
- 23-VIN-0367
- CTRI/2026/02/104919 (Identificativo del registro) (Clinical Trials Registry - India)
Numero NCT
Data di inizio (effettiva)
2026-04
Ultimo aggiornamento pubblicato
2026-03-30
Data di completamento (stimata)
2026-12
Arruolamento (previsto)
48
Tipo di studio
Interventistico
FASE
Fase I
Stato
Non ancora in arruolamento
Parole chiave
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
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Doppio
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleCohort 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) |
SperimentaleCohort 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) |
SperimentaleCohort 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) |
SperimentaleCohort 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) |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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) |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto
Età minima
18 Years
Sessi idonei
Maschio
Accetta volontari sani
Sì
- 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 LimitedContatti principali dello studio
Contatto: Sumit Saxena, 91-9875910291, [email protected]
Contatto: Anmol Aggarwal, [email protected]
1 Centri dello studio in 1 paesi
Gujarat
Veeda Clinical Research Ltd, Ahmedabad, Gujarat, 380015, India
Hiren Prajapati, MD (Pharmacology), Contatto, [email protected]