Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent

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Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent

Study Purpose

This Phase 2 trial will assess the safety, tolerability, efficacy, imaging pharmacodynamics, and pharmacokinetics of RVP-001, a novel manganese-based MRI contrast agent, at three escalating dose levels. RVP-001 will be administered as a single IV bolus to subjects with known gadolinium-enhancing central nervous system (CNS) lesions (for example stable brain tumor or multiple sclerosis) who have recently had a gadolinium-based contrast agent (GBCA)-enhanced MRI of the brain.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Adults of both sexes, aged 18-65 years. 2. Patients with known enhancing CNS lesions, that are: (a) on an ongoing follow-up MRI at up to six week intervals, or (ii) are on imaging surveillance at longer intervals, but who are willing to return for unenhanced MRI at up to six weeks post-administration of RVP-001. 3. Patients who have had a GBCA-enhanced MRI within the past 2 to 7 days which demonstrated focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors, focal inflammatory disorders) including at least one enhancing lesion of minimum 5 mm (long axis) 4. Acceptable renal function.

Exclusion Criteria:

1. Subjects who received either the linear GBCA, gadobenate dimeglumine, or high-relaxivity GBCA, gadopiclenol, for standard-of-care GBCA. 2. Serious non-malignant disease that could compromise protocol objectives in the opinion of the investigator and/or the Sponsor. 3. Patients with clinically significant cardiac disease. 4. MRI incompatibility

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06322342
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Reveal Pharmaceuticals Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Srini Mukundan, M.D./PhD.Vera Hoffman
Principal Investigator Affiliation	Reveal PharmaceuticalsReveal Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Central Nervous System (CNS) Lesions, Brain Metastases, Brain Neoplasms, Brain Neoplasms, Benign, Brain Tumor, Primary, Brain Tumor, Recurrent, Brain Tumors, Brain Cancer, Brain Tumor, Brain Neoplasm, Primary, Multiple Sclerosis, Multiple Sclerosis Brain Lesion, Neurofibroma, Acoustic Neuroma, CNS Tumor, CNS Lesion, CNS Metastases, CNS Cancer, CNS Lymphoma

Additional Details

Subjects will be pre-screened by study site personnel based on their upcoming appointment date for standard of care GBCA-enhanced MR imaging. Subjects may include individuals who have a stable primary brain tumor, metastatic brain tumors, multiple sclerosis, or other gadolinium-enhancing CNS lesions. Screening to select subjects for study participation will occur at or around the time of the subject's scheduled appointment. The appointment for standard of care imaging should take place at the designated study site. Following GBCA-enhanced MRI scan to confirm presence of target lesion(s), a baseline unenhanced MRI scan will be performed prior to RVP-001 injection. Dynamic imaging will be performed in conjunction with RVP-001 injection. Steady state imaging will follow at multiple time points during the first hour following dose administration to characterize the pharmacodynamics of RVP-001 and to assess its ability to enhance visualization of areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. Three dose cohorts are planned. An unenhanced MRI scan follow-up study will be performed between one week and six weeks following the administration of RVP-001. Safety will be evaluated throughout the study by assessing the following parameters: adverse events (AEs), physical examinations, injection site monitoring, electrocardiograms (ECGs), vital signs, clinical laboratory evaluations, medical history, and prior and concomitant medications.

Arms & Interventions

Arms

Experimental: 2 mg/Mn/kg

6 subjects each will receive RVP-001 at a dose of 2 mg Mn/kg

Experimental: 7 mg/Mn/kg

6 subjects each will receive RVP-001 at a dose of 7 mg Mn/kg

Experimental: 12 mg/Mn/kg

6 subjects each will receive RVP-001 at a dose of 12 mg Mn/kg

Interventions

Drug: - RVP-001

MRI contrast agent

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Yale New Haven Hospital, New Haven, Connecticut

Status

Recruiting

Address

Yale New Haven Hospital

New Haven, Connecticut, 06510

Site Contact

Kristin DeFrancesco

[email protected]

203-785-3852

Massachusetts General Hospital, Boston, Massachusetts

Status