Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-27 @ 10:57 AM
Study NCT ID:
NCT05413668
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2022-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
First in Human Study of RVP-001, a New Manganese Based MRI Contrast Agent
Sponsor:
Reveal Pharmaceuticals Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R44CA268392 | NIH | None | https://reporter.nih.gov/quic… | View |