MedTrace Logo

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

NCT04185246 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-11-18

Study results available
· View outcomes & findings →

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

Interventions

DRUG

NH002 (Perflutren Lipid Microspheres) Injectable Suspension

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

DIAGNOSTIC_TEST

Echocardiogram

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

Sponsors & Collaborators

  • StatPlus,Inc.

    collaborator UNKNOWN

  • Trust Bio-sonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Wen-Chung Yu · Taipei Veterans General Hospital, Taiwan

  • Chung-Lieh Hung · Taipei Mackay Memorial Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2020-07-01
Completion
2020-07-01
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04185246 on ClinicalTrials.gov