drugset / Trial / NCT02744248

Phase I , MTD, Pharmacokinetic, Safety/Tolerability, Efficacy of IOP Injection for MRI in Healthy Subjects

NCT02744248 ↗

Phase 1 Completed 24 enrolled MegaPro Biomedical Co. Ltd.
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

EvaluationDrugModalityDoseRoute
Comparator IOP Diagnostic / imaging agent 20 mg/ml Intravenous

Indications

No indication recorded.