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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID: NCT05413668
Run by: Reveal Pharmaceuticals Inc.
People needed: 32
Starts: 2022-05-18
Expected to finish: 2022-08-22
Last updated by the study team: 2025-04-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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
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.

Where it is running

Quotient Sciences — Miami, Florida, United States

Full record on ClinicalTrials.gov

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