drugset / Trial / NCT04185246

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

NCT04185246

Phase 1/2 Completed 36 enrolled Trust Bio-sonics, Inc. StatPlus,Inc. · collab
NaSequentialOpen-labelDiagnostic

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.

Timeline

Start
2019-11-04
Primary completion
2020-07-01
Completion
2020-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject NH002 Diagnostic / imaging agent 2.5 unknown Intravenous
Subject NH002 Diagnostic / imaging agent 5 unknown Intravenous
Subject NH002 Diagnostic / imaging agent 10 unknown Intravenous

Indications