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

Last updated: November 5, 2025
Sponsor: Trust Bio-sonics, Inc.
Overall Status: Completed

Phase

1/2

Condition

Cardiac Disease

Treatment

NH002 (Perflutren Lipid Microspheres) Injectable Suspension

Echocardiogram

Clinical Study ID

NCT04185246
NH002-LV
  • Ages > 20
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subjects 20 years of age or older

  2. Ability to understand and the willingness to provide written informed consent

  3. Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy forcongenital heart disease

  4. Negative pregnancy test within 24 hours of the procedure if subject is a woman ofchildbearing potential

Exclusion

Exclusion Criteria:

  1. Known right-to-left, bidirectional, or transient right-to-left cardiac shunt(s)

  2. Chronic obstructive pulmonary disease

  3. Ejection fraction at screening or baseline <40%

  4. Uncontrolled serious ventricular arrhythmias or at high risk for arrhythmias due toprolongation of the QT interval (QT corrected by Fridericia's formula >450 msec inmales and >470 msec in females)

  5. Clinically significant abnormality in renal and liver function tests (alanineaminotransferase/aspartate aminotransferase >2 × upper limit of normal [ULN]; serumcreatinine > 1.5 × ULN)

  6. Known or suspected hypersensitivity to one or more of the ingredients of NH002,perflutren, or other echocardiographic contrast agent

  7. Received an investigational compound within 30 days before enrolling in the study

  8. Received any contrast agent either intravascularly or orally within 48 hours beforeNH002 administration

  9. Pregnant or lactating female (conception during the study should be avoided)

  10. Serious medical or psychiatric illness/condition likely, in the judgment of theinvestigator, to interfere with compliance to protocol treatment/research

  11. Clinically unstable cardiopulmonary conditions considered not suitable forparticipation in the trial, in the judgment of the investigator

  12. Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg ordiastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolicblood pressure ≤ 90 mmHg)

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: NH002 (Perflutren Lipid Microspheres) Injectable Suspension
Phase: 1/2
Study Start date:
November 04, 2019
Estimated Completion Date:
July 01, 2020

Connect with a study center

  • Taipei Mackay Memorial Hospital

    Taipei, 10449
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Taipei Mackay Memorial Hospital

    Taipei 1668341, 10449
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei 1668341, 11217
    Taiwan

    Site Not Available

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