NCT05413668

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

A Single Center, Double-Blinded, Phase 1a Randomized Study to Evaluate Safety and Pharmacokinetics of a New Manganese Based Magnetic Resonance Imaging (MRI) Contrast Agent, RVP-001, in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Reveal Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The first in human study is intended to evaluate the safety and tolerability of single ascending doses of RVP-001 in healthy adult volunteers, and to determine the pharmacokinetics and elimination of RVP-001 in healthy adult volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	RVP-001	Intravenous administration of RVP-001
DRUG	Placebo	Intravenous administration of saline placebo

Timeline

• Start date: 2022-05-18
• Primary completion: 2022-07-22
• Completion: 2022-08-22
• First posted: 2022-06-10
• Last updated: 2025-04-22
• Results posted: 2023-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study