HealthyPhase 1NCT05413668

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

A Phase 1 study testing RVP-001 in people with Healthy, run by Reveal Pharmaceuticals Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: RVP-001
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 18 May 2022to 22 Aug 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Quotient Sciences
Miami, Florida, 33126

Other trials in United States

About this study

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

The objectives of this trial are:

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

Read the 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.

Conditions: Healthy
Being tested: RVP-001, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RVP-001Drug
Also called MnPyC3A
Intravenous administration of RVP-001
PlaceboDrug
Also called saline
Intravenous administration of saline placebo

Study groups in NCT05413668
Study group	Role	What they receive
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. Receives: Drug: RVP-001
Placebo group	Placebo comparator	4 Cohorts of 2 subjects each will receive placebo (saline). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic (PK) Parameter Cmax
Cmax = maximum observed blood plasma concentration of RVP-001
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
mean % of RVP-001 excreted from urine from 0 -120 hours post dose
Measured: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 May 202222 Aug 2022

First posted10 Jun 2022
Study start18 May 2022
Primary completion22 Jul 2022
Study completion22 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05413668
Sponsor's protocol ID: RVL-101-22
Other IDs: R44CA268392
Status last verified: Apr 2025
First submitted: 26 May 2022
Last updated: 22 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Caravan P. Divalent Manganese Complexes as Potential Replacements for Gadolinium-Based Contrast Agents. Invest Radiol. 2024 Feb 1;59(2):187-196. doi: 10.1097/RLI.0000000000001053. Epub 2023 Dec 1.
PubMed 38038701

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05413668
Acronym / sponsor ID: RVL-101-22
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Reveal Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Collaborators: National Cancer Institute (NCI), Quotient Sciences
Study start: 18 May 2022 (actual)
Primary completion: 22 Jul 2022 (actual)
Study completion: 22 Aug 2022 (actual)
First posted: 10 Jun 2022 (actual)
Results: Posted 23 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objectives of this trial are:

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

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
RVP-001 group	Experimental	Drug: RVP-0014 Cohorts of 6 subjects each will receive RVP-001 at doses of 2, 4, 7 and 12 mg Mn/kg.
Placebo group	Placebo comparator	Drug: Placebo4 Cohorts of 2 subjects each will receive placebo (saline).

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RVP-001Also: MnPyC3AIntravenous administration of RVP-001	Drug	RVP-001 group
PlaceboAlso: salineIntravenous administration of saline placebo	Drug	Placebo group

Primary outcome

Pharmacokinetic (PK) Parameter Cmax
Time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
Cmax = maximum observed blood plasma concentration of RVP-001
PK Parameter Tmax
Time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
tmax = time of maximum observed plasma concentration of RVP-001
PK Parameter t1/2
Time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
t1/2 = terminal elimination half-life of RVP-001
PK Parameter Cl
Time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
Cl = total body clearance calculated after a single IV administration of RVP-001
PK Parameter Vd
Time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
Vd = volume of distribution calculated after a single IV administration of RVP-001

1 secondary outcome

% RVP-001 Dose Excreted
Time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose

Results and safety

Results posted to the registry on 23 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RVP-001: 2 mg Mn/kg	6	6
RVP-001: 4 mg Mn/kg	6	6
RVP-001: 7 mg Mn/kg	6	6
RVP-001: 12 mg Mn/kg	6	6
Placebo Group	8	8

Primary outcome: Pharmacokinetic (PK) Parameter Cmax

Time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nmol/mL

Measure	RVP-001: 2 mg Mn/kg n = 6	RVP-001: 4 mg Mn/kg n = 6	RVP-001: 7 mn Mn/kg n = 6	RVP-001: 12 mg Mn/kg n = 6
Value	264 (21.6)	685 (31.1)	992 (20.2)	1960 (20.3)

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

Primary outcome: PK Parameter Tmax

Time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose. Geometric mean (Full Range). Unit: hours

Measure	RVP-001: 2 mg Mn/kg n = 6	RVP-001: 4 mg Mn/kg n = 6	RVP-001: 7 mn Mn/kg n = 6	RVP-001: 12 mg Mn/kg n = 6
Value	0.065 (0.04 to 0.09)	0.085 (0.04 to 0.17)	0.084 (0.03 to 0.17)	0.091 (0.05 to 0.17)

Primary outcome: PK Parameter t1/2

Time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: hours

Measure	RVP-001: 2 mg Mn/kg n = 6	RVP-001: 4 mg Mn/kg n = 6	RVP-001: 7 mn Mn/kg n = 6	RVP-001: 12 mg Mn/kg n = 6
Value	1.718 (7.4)	1.765 (7.9)	1.613 (7.0)	1.839 (20.2)

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

Primary outcome: PK Parameter Cl

Time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: mL/min

Measure	RVP-001: 2 mg Mn/kg n = 6	RVP-001: 4 mg Mn/kg n = 6	RVP-001: 7 mn Mn/kg n = 6	RVP-001: 12 mg Mn/kg n = 6
Value	122 (18.8)	102 (6.4)	122 (16.3)	97.6 (13.3)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from signing of consent to last study visit - approximately 7 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RVP-001: 2 mg Mn/kg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
RVP-001: 4 mg Mn/kg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
RVP-001: 7 mg Mn/kg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
RVP-001: 12 mg Mn/kg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Placebo Group	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38038701Caravan P. Divalent Manganese Complexes as Potential Replacements for Gadolinium-Based Contrast Agents. Invest Radiol. 2024 Feb 1;59(2):187-196. doi: 10.1097/RLI.0000000000001053. Epub 2023 Dec 1.
Individual participant dataSharing planned: No

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Srinivasan Mukundan, MD study director

Reveal Pharmaceuticals

Jeffrey Levy, MD principal investigator

Quotient Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RVP-001 in people with Healthy, run by Reveal Pharmaceuticals Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic (PK) Parameter Cmax (time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05413668, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.