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RVP-001 for Healthy Subjects
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 weeks3 visits
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
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
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 moreSecondary study objectives
% RVP-001 Dose Excreted
Side effects data
From 2022 Phase 1 trial • 32 Patients • NCT0541366817%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
RVP-001: 2 mg Mn/kg
RVP-001: 7 mg Mn/kg
Placebo Group
RVP-001: 12 mg Mn/kg
RVP-001: 4 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
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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
13,906 Previous Clinical Trials
41,012,000 Total Patients Enrolled
Quotient SciencesIndustry Sponsor
50 Previous Clinical Trials
1,542 Total Patients Enrolled
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