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

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)