drugset / Trial / NCT02744248
Phase I , MTD, Pharmacokinetic, Safety/Tolerability, Efficacy of IOP Injection for MRI in Healthy Subjects
RandomizedParallel-groupDouble-blindDiagnostic
Summary
Study Objectives Primary: To determine MTD and dose limiting toxicities (DLTs) of IOP magnetic resonance imaging (MRI) contrast agent in healthy subjects. Secondary: 1. To characterize the pharmacokinetic profiles of IOP MRI contrast agent in healthy subjects. 2. To evaluate safety/tolerability profiles of IOP MRI contrast agent in healthy subjects. 3. To explore efficacy profiles of IOP MRI contrast agent for liver organ in healthy subjects.
Timeline
- Start
- 2016-02
- Primary completion
- 2016-12
- Completion
- 2017-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | IOP | Diagnostic / imaging agent | 20 mg/ml | Intravenous |
Indications
No indication recorded.