NCT04185246

A Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography

A Multicenter, Open-Label, Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Trust Bio-sonics, Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

NH002 (Perflutren Lipid Microspheres) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular (LV) chamber and to improve the delineation of the LV endocardial border. The primary objective of this study is to evaluate the safety and tolerability of 3 ascending doses of NH002.

Conditions

• Cardiac Disease

Interventions

Type	Name	Description
DRUG	NH002 (Perflutren Lipid Microspheres) Injectable Suspension	NH002 is formulated as a microbubble injectable suspension for intravenous administration. NH002 requires an activation process prior to use.
DIAGNOSTIC_TEST	Echocardiogram	Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day.

Timeline

• Start date: 2019-11-04
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2019-12-04
• Last updated: 2025-11-18
• Results posted: 2024-12-20

Locations

2 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study