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

• Status: Active, not recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Microvascular Therapeutics, LLC
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH); University of Nebraska

Criteria

Inclusion Criteria:

• Adult subjects 19 years of age or older, male or female

• Female subjects must no longer have child-bearing potential (>1-year post menopause or surgically sterilized), or must

• have a negative urine pregnancy test, and

• be using and continue to use for 30 days after the study a medically effective method of contraception

• Adequate hematologic, renal and hepatic function, as defined by:

• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

• Platelet count ≥ 100 x 109/L

• Hemoglobin ≥ 90 g/L

• Plasma creatinine< 1.5 x ULN

• Total bilirubin within normal limits (< 2.5 x ULN if Gilbert's syndrome)

• Aspartate transaminase (AST) and Alanine transaminase (ALT) < 2.5 x ULN

• Subject must be willing and able to understand the study and provide written Informed Consent to participate in the study

Exclusion Criteria:

• Myocardial infarction within six months prior to enrollment

• Unstable angina, NYHA Class II or greater congestive heart failure

• EKG evidence of uncontrolled arrhythmia or history of clinically significant arrhythmia within the past six months

• Clinically significant Chronic Obstructive Pulmonary Disease (COPD) or other pulmonary condition that is not controlled by medication or requires oxygen frequently or continuously

• A history of pulmonary emboli

• Known hypersensitivity to perflutren, DEFINITY® or other echo contrast agent

• Inability to remain supine for 60 minutes

• Oxygen saturation < 95% on room air

• History of allergic reaction attributed to compounds of similar chemical composition to MVT-100 or DEFINITY® or soy or egg allergies (see Investigator's Brochure)

• Subject has received any investigational drug within thirty (30) days prior to enrollment into the study

• Inability to comply with study procedures

• Subjects with any medical condition deemed by the investigator to make the subject inappropriate for participation