First in Human Study of RVP-001, a New Manganese Based MRI Contrast Agent

Phase 1 Completed 32 enrolled Reveal Pharmaceuticals Inc. National Cancer Institute (NCI) · collab Quotient Sciences · collab

RandomizedParallel-groupQuadruple-blindOther

Summary

The objectives of this trial are: 1. To evaluate the safety and tolerability of single ascending doses of RVP-001 in healthy adult volunteers 2. To determine the pharmacokinetics and elimination of RVP-001 in healthy adult volunteers.

Timeline

Start: 2022-05-18
Primary completion: 2022-07-22
Completion: 2022-08-22

Publications

Caravan P. Divalent Manganese Complexes as Potential Replacements for Gadolinium-Based Contrast Agents. Invest Radiol. 2024 Feb 1;59(2):187-196. doi: 10.1097/RLI.0000000000001053. Epub 2023 Dec 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RVP-001	Diagnostic / imaging agent	2 mg/kg	Intravenous
Subject	RVP-001	Diagnostic / imaging agent	4 mg/kg	Intravenous
Subject	RVP-001	Diagnostic / imaging agent	7 mg/kg	Intravenous
Subject	RVP-001	Diagnostic / imaging agent	12 mg/kg	Intravenous

Indications

No indication recorded.