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

Phase 1
Waitlist Available
Led By Jeffrey Levy, MD
Research Sponsored by Reveal Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose

Summary

This trial tests a new drug called RVP-001 to see if it is safe for people to use. Healthy adults are participating to ensure the drug doesn't cause harm. Researchers will also study how the drug moves through and leaves the body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PK Parameter Cl
PK Parameter Tmax
PK Parameter Vd
+2 more
Secondary study objectives
% RVP-001 Dose Excreted

Side effects data

From 2022 Phase 1 trial • 32 Patients • NCT05413668
17%
Presyncope
17%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
RVP-001: 7 mg Mn/kg
RVP-001: 2 mg Mn/kg
RVP-001: 4 mg Mn/kg
Placebo Group
RVP-001: 12 mg Mn/kg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RVP-001 groupExperimental Treatment1 Intervention
4 Cohorts of 6 subjects each will receive RVP-001 at doses of 2, 4, 7 and 12 mg Mn/kg.
Group II: Placebo groupPlacebo Group1 Intervention
4 Cohorts of 2 subjects each will receive placebo (saline).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RVP-001
2022
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Reveal Pharmaceuticals Inc.Lead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,138 Total Patients Enrolled
Quotient SciencesIndustry Sponsor
50 Previous Clinical Trials
1,542 Total Patients Enrolled
Jeffrey Levy, MDPrincipal InvestigatorQuotient Sciences
1 Previous Clinical Trials
36 Total Patients Enrolled
Vera HoffmanPrincipal InvestigatorReveal Pharmaceuticals
1 Previous Clinical Trials
24 Total Patients Enrolled
Srinivasan Mukundan, MDStudy DirectorReveal Pharmaceuticals
~9 spots leftby Dec 2025
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