Title
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
Phase
Phase 1Lead Sponsor
Trust Bio-sonics, Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Cardiac DiseaseIntervention/Treatment
NH002 (Perflutren Lipid Microspheres) Injectable Suspension ...Study Participants
36NH002 (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.
NH002 is formulated as a microbubble injectable suspension for intravenous administration. NH002 requires an activation process prior to use.
Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day.
Subjects will be enrolled with sequential allocation to 1 of 3 cohorts with the following intravenous (IV) doses of NH002: 2.5 µl/kg, 5.0 µl/kg, or 10.0 µl/kg. Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day
Inclusion Criteria: Male or female subjects 20 years of age or older Ability to understand and the willingness to provide written informed consent Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for congenital heart disease Negative pregnancy test within 24 hours of the procedure if subject is a woman of childbearing potential Exclusion Criteria: Known right-to-left, bidirectional, or transient right-to-left cardiac shunt(s) Chronic obstructive pulmonary disease Ejection fraction at screening or baseline <40% Uncontrolled serious ventricular arrhythmias or at high risk for arrhythmias due to prolongation of the QT interval (QT corrected by Fridericia's formula >450 msec in males and >470 msec in females) Clinically significant abnormality in renal and liver function tests (alanine aminotransferase/aspartate aminotransferase >2 × upper limit of normal [ULN]; serum creatinine > 1.5 × ULN) Known or suspected hypersensitivity to one or more of the ingredients of NH002, perflutren, or other echocardiographic contrast agent Received an investigational compound within 30 days before enrolling in the study Received any contrast agent either intravascularly or orally within 48 hours before NH002 administration Pregnant or lactating female (conception during the study should be avoided) Serious medical or psychiatric illness/condition likely, in the judgment of the investigator, to interfere with compliance to protocol treatment/research Clinically unstable cardiopulmonary conditions considered not suitable for participation in the trial, in the judgment of the investigator Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg)
