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

NCT04185246 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: NH002-LV
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Echo; Echocardiogram; Cardiac ultrasound; suboptimal; contrast agent; enhancing agent; LVO; LVEBD

Outcome Measures

Primary Outcomes (10)

• 12-lead ECGs

  Standard 12-lead ECGs will be assessed from pre-injection to 60 minutes post-injection for changes in QT/ corrected QT(QTc) interval (in ms) and ECG morphology; each standard 12-lead ECG assessment will be scored as either normal or abnormal

  From pre-injection to 60 minutes post injection

• Body Temperature

  Monitor for any changes in body temperature (in Celsius degree)

  From pre-injection to 120 minutes post injection

• Heart Rate

  Monitor for any changes in heart rate (in beats/min)

  From pre-injection to 120 minutes post injection

• Respiratory Rate

  Monitor for any changes in respiratory rate (in breaths/min)

  From pre-injection to 120 minutes post injection

• Blood Pressure

  Monitor for any changes in blood pressure (in mmHg)

  From pre-injection to 120 minutes post injection

• Thrombin Time (TT) and Activated Partial Thromboplastin Time (aPTT)

  Monitor for any changes in TT and aPTT

  From pre-injection to 240 minutes post-injection

• Cardiac Troponin I

  Monitor for any changes in Cardiac troponin I

  pre-injection and 240 minutes post-injection

• Oxygen Saturation by Pulse Oximetry (SpO2)

  Monitor for any changes in SpO2

  From pre-injection to 120 minutes post-injection

• Rate of Any Potential Adverse Allergic Reaction

  Monitor for any potential adverse allergic reaction

  From pre-injection to 240 minutes post-injection

• Cardiac Troponin T

  Monitor for any changes in Cardiac troponin T

  pre-injection and 240 minutes post-injection

Secondary Outcomes (3)

• Left Ventricular Opacification (LVO)

  Image data obtained pre-injection and within 10 minutes post-injection

• Left Ventricular Endocardial Border Delineation (LVEBD)

  Image data obtained pre-injection and within 10 minutes post-injection

• Duration of Clinically Useful Contrast

  Image data obtained pre-injection and within 10 minutes post-injection

Study Arms (1)

Single arm

EXPERIMENTAL

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

Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension; Diagnostic Test: Echocardiogram

Interventions

NH002 (Perflutren Lipid Microspheres) Injectable Suspension DRUG

NH002 is formulated as a microbubble injectable suspension for intravenous administration. NH002 requires an activation process prior to use.

Single arm

Echocardiogram DIAGNOSTIC_TEST

Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day.

Single arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Trust Bio-sonics, Inc.: lead
• StatPlus,Inc.: collaborator

Study Sites (2)

Taipei Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Results Point of Contact

• Title: Charly Kang
• Organization: Trust Biosonics, Inc.

charlykang@trust-biosonics.com

+886-3-668-4965

Study Officials

• Wen-Chung Yu

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

• Chung-Lieh Hung

  Taipei Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: The reviewer of echocardiograms in this trial is blinded to the treatment assignments and subject identifiers.
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: December 4, 2019
• Study Start: November 4, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: November 18, 2025
• Results First Posted: December 20, 2024

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)