An Ascending Dose Comparison of MVT-100 to Definity in Healthy Volunteers
Status:
Active, not recruiting
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
Summary
Definity (perflutren lipid microspheres, Lantheus Medical Imaging) is an ultrasound contrast
indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular
chamber and to improve the delineation of the left ventricular endocardial border. MVT-100
(the investigational pharmaceutical) is similar to Definity, with the exception of the
removal of one lipid in the lipid blend and substitution of another lipid. This study is
intended to evaluate the safety and efficacy of MVT-100 using a single ascending dose design
in healthy volunteers. Patients are randomized to receive either MVT-100 or Definity and
undergo echocardiograms after receiving either MVT-100 or Definity via bolus or IV infusion
administration. The primary endpoints evaluated are safety and endocardial border
delineation.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Microvascular Therapeutics, LLC
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI) National Institutes of Health (NIH) University of Nebraska