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

Sponsor
Reveal Pharmaceuticals Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05413668
Collaborator
National Cancer Institute (NCI) (NIH), Quotient Sciences (Industry)
32
Enrollment
1
Location
2
Arms
6.5
Anticipated Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
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
Actual Study Start Date :
May 18, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: RVP-001 group

will receive RVP-001

Drug: RVP-001
Intravenous administration of RVP-001
Other Names:
  • MnPyC3A

    		•
    Placebo Comparator: Placebo group

    will receive placebo

    Drug: Placebo
    Intravenous administration of saline placebo
    Other Names:
  • saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetic (PK) Parameter Cmax [5 days]

      Cmax = maximum observed blood plasma concentration of RVP-001

    2. PK parameter tmax [5 days]

      tmax = time of maximum observed plasma concentration of RVP-001

    3. PK parameter t1/2 [5 days]

      t1/2 = terminal elimination half-life of RVP-001

    4. PK parameter Cl [5 days]

      Cl = total body clearance calculated after a single IV administration of RVP-001

    5. PK Parameter Vd [5 days]

      Vd = volume of distribution calculated after a single IV administration of RVP-001

    Secondary Outcome Measures

    1. Urinanalysis [5 days]

      Urinary concentrations and cumulative amounts of RVP-001 excreted will be determined and summarized by dose level.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Quotient Sciences Miami Florida United States 33126

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Srinivasan Mukundan, MD, Reveal Pharmaceuticals
    • Principal Investigator: Vera Hoffman, Reveal Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Reveal Pharmaceuticals Inc.
    ClinicalTrials.gov Identifier:
    NCT05413668
    Other Study ID Numbers:
    • RVL-101-22
    • R44CA268392
    First Posted:
    Jun 10, 2022
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 2, 2022