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

Reveal Pharmaceuticals Inc.1 个研究点分布在 1 个国家目标入组 32 人开始时间: 2022年5月18日最近更新: 2025年4月22日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 32
试验地点: 1
主要终点: Pharmacokinetic (PK) Parameter Cmax

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Other
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•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.

研究组 & 干预措施

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.

干预措施: RVP-001 (Drug)

Placebo group

Placebo Comparator

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

干预措施: Placebo (Drug)