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

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.