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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: RVP-001; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • Quotient Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female subjects
2. Healthy subjects aged 18 to 55 years inclusive
3. Suitable veins for phlebotomy, cannulation, or repeated venipuncture
4. Have a body mass index between 18 and 32 kg/m^2 (inclusive); weigh at least 55 kg.
5. Appropriately completed written informed consent prior to any study specific procedures.

Exclusion Criteria:

1. Any clinically significant abnormality or abnormal laboratory test results found during medical screening
2. Vital sign abnormalities at screening or admission
3. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease; neurological or psychiatric disorder, as judged by the investigator
4. Positive pregnancy test at screening or admission
5. History of alcohol abuse
6. History of drug abuse
7. Use of nicotine-containing products within 12 months of study start
8. Use of medication except topical products without significant systemic absorption
9. Known allergies to any component of RVP-001
10. Subjects who have received any investigational product (IP) in a clinical research study within 5 IP half-lives or 30 days prior to first dose.
11. Donation of plasma within 7 days prior to dosing; significant donation or loss of blood within 30 days prior to the first dosing.
12. Any reason which, in the opinion of the Principal Investigator, would prevent the subject from participating in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RVP-001 group; 4 Cohorts of 6 subjects each will receive RVP-001 at doses of 2, 4, 7 and 12 mg Mn/kg.	Drug: RVP-001; Intravenous administration of RVP-001; Other Names: MnPyC3A
Placebo Comparator: Placebo group; 4 Cohorts of 2 subjects each will receive placebo (saline).	Drug: Placebo; Intravenous administration of saline placebo; Other Names: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) Parameter Cmax	Cmax = maximum observed blood plasma concentration of RVP-001	pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
PK Parameter Tmax	tmax = time of maximum observed plasma concentration of RVP-001	pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
PK Parameter t1/2	t1/2 = terminal elimination half-life of RVP-001	pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
PK Parameter Cl	Cl = total body clearance calculated after a single IV administration of RVP-001	pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
PK Parameter Vd	Vd = volume of distribution calculated after a single IV administration of RVP-001	pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% RVP-001 Dose Excreted	mean % of RVP-001 excreted from urine from 0 -120 hours post dose	pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose

Collaborators and Investigators

• Sponsor: Reveal Pharmaceuticals Inc.
• Collaborators: National Cancer Institute (NCI); Quotient Sciences
• Investigators: Study Director: Srinivasan Mukundan, MD, Reveal Pharmaceuticals; Principal Investigator: Jeffrey Levy, MD, Quotient Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Actual): July 22, 2022
• Study Completion (Actual): August 22, 2022

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: RVL-101-22; R44CA268392 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No