Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent
Summary
This Phase 2 clinical trial will study RVP-001, a new manganese-based MRI contrast agent, in people who are known to have gadolinium-enhancing central nervous system (CNS) lesions, for example brain tumors or multiple sclerosis. The goal of this study is to assess safety, efficacy, and pharmacokinetics of RVP-001 at three dose levels. The study will also compare RVP-001 imaging to gadolinium-based contrast agent (GBCA) imaging. A single dose of RVP-001 will be administered to each subject. Subjects will have known gadolinium-enhancing CNS lesions and will have a gadolinium-based contrast agent-enhanced MRI of the brain 2-14 days before receiving RVP-001 with imaging. The ultimate goal of this research program is development of a gadolinium-free alternative to current general purpose MRI contrast agents.
Timeline
- Start
- 2024-08-15
- Primary completion
- 2025-12-19
- Completion
- 2025-12-19