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

NCT05413668 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: RVL-101-22R44CA268392
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this trial are:

1. 1.To evaluate the safety and tolerability of single ascending doses of RVP-001 in healthy adult volunteers
2. 2.To determine the pharmacokinetics and elimination of RVP-001 in healthy adult volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• % RVP-001 Dose Excreted

  pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose

Study Arms (2)

RVP-001 group

EXPERIMENTAL

4 Cohorts of 6 subjects each will receive RVP-001 at doses of 2, 4, 7 and 12 mg Mn/kg.

Drug: RVP-001

Placebo group

PLACEBO COMPARATOR

4 Cohorts of 2 subjects each will receive placebo (saline).

Drug: Placebo

Interventions

RVP-001 DRUG

Intravenous administration of RVP-001

Also known as: MnPyC3A

RVP-001 group

Placebo DRUG

Intravenous administration of saline placebo

Also known as: saline

Placebo group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Any clinically significant abnormality or abnormal laboratory test results found during medical screening
• Vital sign abnormalities at screening or admission
• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease; neurological or psychiatric disorder, as judged by the investigator
• Positive pregnancy test at screening or admission
• History of alcohol abuse
• History of drug abuse
• Use of nicotine-containing products within 12 months of study start
• Use of medication except topical products without significant systemic absorption
• Known allergies to any component of RVP-001
• 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.
• Donation of plasma within 7 days prior to dosing; significant donation or loss of blood within 30 days prior to the first dosing.
• Any reason which, in the opinion of the Principal Investigator, would prevent the subject from participating in the study.

Sponsors & Collaborators

• Reveal Pharmaceuticals Inc.: lead
• National Cancer Institute (NCI): collaborator
• Quotient Sciences: collaborator

Study Sites (1)

Quotient Sciences

Miami, Florida, 33126, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Jeffrey Levy
• Organization: Quotient Sciences

jeffrey.levy@quotientsciences.com

+44 (0)115 974 9000

Study Officials

• Srinivasan Mukundan, MD

  Reveal Pharmaceuticals

  STUDY DIRECTOR

• Jeffrey Levy, MD

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 10, 2022
• Study Start: May 18, 2022
• Primary Completion: July 22, 2022
• Study Completion: August 22, 2022
• Last Updated: April 22, 2025
• Results First Posted: October 23, 2023

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)