An Ascending Dose Comparison of MVT-100 to Definity in Healthy Volunteers

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

April 25, 2019

Primary Completion Date

September 30, 2024

Study Completion Date

May 6, 2025

Conditions
Heart Diseases
Interventions
DIAGNOSTIC_TEST

Echocardiogram

"Images will be recorded in parasternal long, short axis, apical four, two, and three chamber views according to the American Society of Echocardiography (ASE) 17 segment model. Each assessment will include one round of low MI imaging (\<0.3) and one round of very low MI imaging (\<0.2) in each of the pre-specified windows according to the 2014 ASE Sonographer Guidelines.~A baseline echocardiogram will be performed prior to the administration of DEFINITY® or MVT-100. Assessments will be made three times, once from 0 - 1 ½ minutes following injection, once between 1 ½ minutes to 3 minutes following IV injection and once from 3 - 4 ½ minutes following IV injection. Assessments at each time point will include one round of low MI imaging (\<0.3) and one round of very low MI imaging (\<0.2). Each round will include the views in the following order: parasternal long, parasternal short, apical 4, apical 2 and apical 3."

DRUG

MVT-100

After randomization, MVT-100, the experimental drug, is administered via IV infusion or bolus administration and echocardiograms are subsequently obtained.

DRUG

Definity

After randomization, Definity, the active comparator, is administered via IV infusion or bolus administration and echocardiograms are subsequently obtained.

Trial Locations (2)

64111

Saint Luke's Hospital of Kansas City, Kansas City

68198

University of Nebraska Medical Center, Omaha

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

University of Nebraska

OTHER

lead

Microvascular Therapeutics, LLC

INDUSTRY

NCT03882359 - An Ascending Dose Comparison of MVT-100 to Definity in Healthy Volunteers | Biotech Hunter | Biotech Hunter