IA Trial Radar | ||
|---|---|---|
O estudo clínico NCT07502144 (VRP-034) para Voluntários saudáveis está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
Um estudo corresponde aos critérios do filtro
Visualização em cartões
A Phase I Study Comparing the Safety, Pharmacokinetics and Renal Effects of VRP-034 and Marketed Polymyxin B in Healthy Volunteers Fase I 48 Baseado em biomarcador Randomizado Duplo-cego Escalonamento de dose
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07502144 (VRP-034) vai avaliar tratamento para Voluntários saudáveis. Este é um estudo intervencionista de Fase I. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de abril de 2026, com o objetivo de incluir 48 participantes. Coordenado por Venus Remedies Limited e deve ser concluído em 1 de dezembro de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 30 de março de 2026.
Resumo
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...
Mostrar maisTítulo oficial
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
Condições médicas
Voluntários saudáveisPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- VRP-034
- 23-VIN-0367
- CTRI/2026/02/104919 (Identificador de registro) (Clinical Trials Registry - India)
Número NCT
Data de início (real)
2026-04
Última atualização postada
2026-03-30
Data de conclusão (estimada)
2026-12
Inscrição (estimada)
48
Tipo de estudo
Intervencionista
FASE
Fase I
Status
Ainda não recrutando
Palavras-chave
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
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Duplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalCohort 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) |
ExperimentalCohort 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) |
ExperimentalCohort 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) |
ExperimentalCohort 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) |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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) |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 de participação
Critérios de elegibilidade
Idades elegíveis
Adulto
Idade mínima
18 Years
Sexos elegíveis
Masculino
Aceita voluntários saudáveis
Sim
- 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 LimitedContato central do estudo
Contato: Sumit Saxena, 91-9875910291, [email protected]
Contato: Anmol Aggarwal, [email protected]
1 Locais do estudo em 1 países
Gujarat
Veeda Clinical Research Ltd, Ahmedabad, Gujarat, 380015, India
Hiren Prajapati, MD (Pharmacology), Contato, [email protected]