NCT06010537

Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle

A Single-center, Randomized, Open-label, Single-dose Study of Polysaccharide Superparamagnetic Iron Oxide Injection in Healthy Subjects to Evaluate Magnetic Resonance Imaging in Multiple Dose Groups

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a contrast-enhanced magnetic resonance imaging (MRI) study conducted on a single-administration of polyglucose superparamagnetic iron oxide injection. Two dose groups are set up in this study, 2.5 mg/kg and 3 mg/kg, and two subjects in each group received the test drug for safety evaluation.

Conditions

• Magnetic Resonance Imaging

Interventions

Type	Name	Description
DRUG	polysaccharide superparamagnetic iron oxide injection	Polysaccharide superparamagnetic iron oxide injection is a magnetic resonance contrast agent.

Timeline

• Start date: 2021-04-28
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2023-08-24
• Last updated: 2023-08-25

Locations

1 site across 1 country: China