Study to Evaluate the Effects of MEDI6012 on Apolipoprotein B100 Metabolism
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|ClinicalTrials.gov Identifier: NCT03773172|
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : April 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Drug: MEDI6012 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Study to Evaluate the Effects of Two Doses Over 48 Hours of MEDI6012 on Apolipoprotein B100 Metabolism in Subjects With Stable Atherosclerotic Cardiovascular Disease|
|Actual Study Start Date :||January 31, 2019|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||May 2020|
Placebo Comparator: Placebo Control Group
Subjects will receive placebo treatment to mimic active treatment.
The placebo will mimic the active treatment.
Other Name: Placebo compound provided by funding agency
Active Comparator: Active treatment
IV push loading dose of 300 mg MEDI6012 followed by a 150 mg maintenance dose of MEDI6012 at 48 hours.
MEDI6012 is recombinant human lecithin-cholesterol acyltransferase (rhLCAT), an approximately 60 kilodalton, glycosylated, single-chain protein consisting of 416 amino acids produced via Chinese hamster ovary cell culture. It is being explored as an acute treatment to reduce the risk of recurrent cardiovascular events as an adjunct to the standard of care in patients with acute myocardial infarction (MI). MEDI6012 and ACP501 have the identical amino acid sequence and are therefore considered the same molecular entity.
Other Name: Stable Isotopes
- Percent Change in FCR of LDL-apoB100 (pools/day) [ Time Frame: Up to 48 hours from first dose ]Fractional Clearance Rate (FCR) of lipoprotein B.
- PR of LDL apoB100 (mg/kg/day) [ Time Frame: Up to 48 hours from first dose ]Production Rate (PR) of LDL apoB 100.
- ADA Measurement [ Time Frame: Up to 60 days post administration of first dose ]To access the immunogenicity of MEDI6012, anti-drug antibodies (ADA) will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773172
|Contact: Henry Ginsberg, MDemail@example.com|
|Contact: Gissette Reyes-Soffer, MDfirstname.lastname@example.org|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Gissette Reyes-Soffer, MD 212-305-9298 email@example.com|
|Contact: Henry Ginsberg, MD 212-305-9562 firstname.lastname@example.org|
|Principal Investigator: Henry Ginsberg, MD|
|Sub-Investigator: Gissette Reyes-Soffer, MD|
|Principal Investigator:||Henry Ginsberg, MD||Columbia University|