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

Reveal Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: RVP-001

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT05413668

R44CA268392 (U.S. NIH Grant/Contract)

RVL-101-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

RVP-001 group

Experimental group

Description:

4 Cohorts of 6 subjects each will receive RVP-001 at doses of 2, 4, 7 and 12 mg Mn/kg.

Treatment:

Drug: RVP-001

Placebo group

Placebo Comparator group

Description:

4 Cohorts of 2 subjects each will receive placebo (saline).

Treatment:

Drug: Placebo