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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05413668
Enrollment
32
Registered
2022-06-10
Start date
2022-05-18
Completion date
2022-08-22
Last updated
2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

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.

Interventions

DRUGRVP-001

Intravenous administration of RVP-001

DRUGPlacebo

Intravenous administration of saline placebo

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Quotient Sciences
CollaboratorINDUSTRY
Reveal Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Pharmacokinetic (PK) Parameter Cmaxpre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-doseCmax = maximum observed blood plasma concentration of RVP-001
PK Parameter Tmaxpre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dosetmax = time of maximum observed plasma concentration of RVP-001
PK Parameter t1/2pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-doset1/2 = terminal elimination half-life of RVP-001
PK Parameter Clpre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-doseCl = total body clearance calculated after a single IV administration of RVP-001
PK Parameter Vdpre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-doseVd = volume of distribution calculated after a single IV administration of RVP-001

Secondary

MeasureTime frameDescription
% RVP-001 Dose Excretedpre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dosemean % of RVP-001 excreted from urine from 0 -120 hours post dose

Countries

United States

Participant flow

Participants by arm

ArmCount
RVP-001: 2 mg Mn/kg
6 subjects received RVP-001 in a single dose of 2 mg Mn/kg administered via automated injection pump
6
RVP-001: 4 mg Mn/kg
6 subjects received RVP-001 in a single dose of 4 mg Mn/kg administered via automated injection pump
6
RVP-001: 7 mg Mn/kg
6 subjects received RVP-001 in a single dose of 7 mg Mn/kg administered via automated injection pump
6
RVP-001: 12 mg Mn/kg
6 subjects received RVP-001 in a single dose of 12 mg Mn/kg administered via automated injection pump
6
Placebo Group
8 subjects received placebo (saline) administered via automated injection pump
8
Total32

Baseline characteristics

CharacteristicRVP-001: 2 mg Mn/kgRVP-001: 4 mg Mn/kgRVP-001: 7 mg Mn/kgRVP-001: 12 mg Mn/kgPlacebo GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
6 Participants6 Participants6 Participants6 Participants8 Participants32 Participants
Age, Continuous38.3 years35.3 years30.3 years44.3 years39.0 years38.53 years
BMI26.03 kg/m^226.95 kg/m^226.93 kg/m^227.08 kg/m^227.66 kg/m^226.98 kg/m^2
Body Weight72.97 Kg77.57 Kg79.00 Kg76.83 Kg81.09 Kg77.72 Kg
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants6 Participants6 Participants6 Participants8 Participants32 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Height167.5 cm169.3 cm170.8 cm168.0 cm171.0 cm169.4 cm
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants3 Participants0 Participants3 Participants7 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
5 Participants6 Participants3 Participants6 Participants5 Participants25 Participants
Sex: Female, Male
Female
1 Participants2 Participants2 Participants3 Participants2 Participants10 Participants
Sex: Female, Male
Male
5 Participants4 Participants4 Participants3 Participants6 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 60 / 60 / 60 / 8
other
Total, other adverse events
1 / 62 / 62 / 60 / 61 / 8
serious
Total, serious adverse events
0 / 60 / 60 / 60 / 60 / 8

Outcome results

Primary

Pharmacokinetic (PK) Parameter Cmax

Cmax = maximum observed blood plasma concentration of RVP-001

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

Population: All subjects who received at least one dose of RVP-001 and had sufficient data to calculate at least one PK parameter

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
RVP-001: 2 mg Mn/kgPharmacokinetic (PK) Parameter Cmax264 nmol/mLGeometric Coefficient of Variation 21.6
RVP-001: 4 mg Mn/kgPharmacokinetic (PK) Parameter Cmax685 nmol/mLGeometric Coefficient of Variation 31.1
RVP-001: 7 mn Mn/kgPharmacokinetic (PK) Parameter Cmax992 nmol/mLGeometric Coefficient of Variation 20.2
RVP-001: 12 mg Mn/kgPharmacokinetic (PK) Parameter Cmax1960 nmol/mLGeometric Coefficient of Variation 20.3
Primary

PK Parameter Cl

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

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

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
RVP-001: 2 mg Mn/kgPK Parameter Cl122 mL/minGeometric Coefficient of Variation 18.8
RVP-001: 4 mg Mn/kgPK Parameter Cl102 mL/minGeometric Coefficient of Variation 6.4
RVP-001: 7 mn Mn/kgPK Parameter Cl122 mL/minGeometric Coefficient of Variation 16.3
RVP-001: 12 mg Mn/kgPK Parameter Cl97.6 mL/minGeometric Coefficient of Variation 13.3
Primary

PK Parameter t1/2

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

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

Population: All subjects who received at least one dose of RVP-001 and had sufficient data to calculate at least one PK parameter

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
RVP-001: 2 mg Mn/kgPK Parameter t1/21.718 hoursGeometric Coefficient of Variation 7.4
RVP-001: 4 mg Mn/kgPK Parameter t1/21.765 hoursGeometric Coefficient of Variation 7.9
RVP-001: 7 mn Mn/kgPK Parameter t1/21.613 hoursGeometric Coefficient of Variation 7
RVP-001: 12 mg Mn/kgPK Parameter t1/21.839 hoursGeometric Coefficient of Variation 20.2
Primary

PK Parameter Tmax

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

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

ArmMeasureValue (GEOMETRIC_MEAN)
RVP-001: 2 mg Mn/kgPK Parameter Tmax0.065 hours
RVP-001: 4 mg Mn/kgPK Parameter Tmax0.085 hours
RVP-001: 7 mn Mn/kgPK Parameter Tmax0.084 hours
RVP-001: 12 mg Mn/kgPK Parameter Tmax0.091 hours
Primary

PK Parameter Vd

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

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

Population: All subjects who received at least one dose of RVP-001 and had sufficient data to calculate at least one PK parameter

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
RVP-001: 2 mg Mn/kgPK Parameter Vd18.2 LitersGeometric Coefficient of Variation 17.8
RVP-001: 4 mg Mn/kgPK Parameter Vd15.6 LitersGeometric Coefficient of Variation 8.8
RVP-001: 7 mn Mn/kgPK Parameter Vd17.1 LitersGeometric Coefficient of Variation 18.4
RVP-001: 12 mg Mn/kgPK Parameter Vd15.5 LitersGeometric Coefficient of Variation 22.7
Secondary

% RVP-001 Dose Excreted

mean % of RVP-001 excreted from urine from 0 -120 hours post dose

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

ArmMeasureValue (MEAN)Dispersion
RVP-001: 2 mg Mn/kg% RVP-001 Dose Excreted66.398 Mean % of dose recovered 0-120 hrsStandard Deviation 7.372
RVP-001: 4 mg Mn/kg% RVP-001 Dose Excreted73.623 Mean % of dose recovered 0-120 hrsStandard Deviation 7.768
RVP-001: 7 mn Mn/kg% RVP-001 Dose Excreted80.924 Mean % of dose recovered 0-120 hrsStandard Deviation 12.347
RVP-001: 12 mg Mn/kg% RVP-001 Dose Excreted74.90 Mean % of dose recovered 0-120 hrsStandard Deviation 15.23

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026