Back to resultsTo Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MEDI6012
Placebo SC
Placebo IV
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, CAD
Eligibility Criteria
Inclusion Criteria:
- Men and women 40 - 75 years old
- History of Stable CAD
- Currently receiving statin as standard of care
Exclusion Criteria:
- Severe angina pectoris symptoms
- High-risk coronary or carotid artery disease that will likely require surgical or percutaneous intervention during the study period
- Hospitalization for heart failure within 12 months prior to screening
- Uncontrolled Hypertension
- Within 6 months prior to screening, a history of ACS or hospitalization for heart failure
- Clinically significant abnormalities in rhythm, conduction or morphology of ECG
- Subjects with transplanted heart, left ventricular assist device, implanted pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy
- Untreated life-threatening ventricular arrhythmias
- History, within 12 months prior to screening, of myocarditis or restrictive pericarditis, or hemodynamically significant valvular hear disease or aortic disease
- Undergone major surgery with in 3 months prior to screening or has planned major surgery during the study period
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
MEDI6012 24 mg IV
MEDI6012 80 mg IV
MEDI6012 240 mg IV
MEDI6012 800 mg IV
MEDI6012 80 mg SC
Placebo Intravenous (IV)
MEDI6012 600 mg SC
Placebo Subcutaneous (SC)
Arm Description
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Number of Participants With TEAEs Related to Electrocardiogram (ECG) Evaluations
TEAEs observed in participants with clinically significant ECG abnormalities were assessed. TEAEs are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Number of Participants With TEAEs Related to Vital Sign Parameters
TEAEs observed in participants with clinically significant vital signs abnormalities were assessed. Vital signs parameters included blood pressure, respiration rate, pulse, pulse oximetry, and body temperature.
Number of Participants With TEAEs Related to Clinical Laboratory Evaluations
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hours (Hrs) (AUC [0-96 Hrs]) for High-Density Lipoprotein-Cholesterol (HDL-C)
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of HDL-C.
Secondary Outcome Measures
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Total Cholesterol
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of total cholesterol.
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Free Cholesterol
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of free cholesterol.
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Cholesteryl Ester
The AUC(0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of cholesteryl ester.
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Cholesteryl Ester
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of high density lipoprotein cholesteryl ester.
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesterol
The AUC(0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein cholesterol.
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Unesterified Cholesterol
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of high density lipoprotein unesterified cholesterol.
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesteryl Ester
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein cholesteryl ester.
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Unesterified Cholesterol
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein unesterified cholesterol.
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Low Density Lipoprotein-Cholesterol (Direct)
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of low density lipoprotein cholesterol (direct).
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) Post Dose for Apolipoprotein B
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of apolipoprotein B.
Change From Baseline in Serum Concentration of Pre Beta 1-High Density Lipoprotein at Day 29
The change from baseline in serum concentration of pre beta 1-high density lipoprotein was estimated.
Change From Baseline in Serum Concentration of Lecithin-Cholesterol Acyltransferase (LCAT) at Day 57
The change from baseline in serum concentration of lecithin-cholesterol acyltransferase was estimated.
Maximum Observed Serum Concentration (Cmax) of MEDI6012
The first occurrence of the maximum observed plasma concentration of MEDI6012 determined directly from the raw concentration time data.
Time to Reach Concentration Maximum (Tmax) of MEDI6012
The time at which Cmax of MEDI6012 was observed determined directly from raw concentration time data.
Area Under the Concentration Time Curve From 0 to 168 Hrs (AUC [0-168]) of MEDI6012
The area under the concentration-time curve from 0 to 168 hrs of MEDI6012.
Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Concentration (AUC [0-last]) of MEDI6012
Area under the plasma concentration time-curve from zero to the last measured concentration (AUC [0-last]) of MEDI6012.
Area Under the Concentration Time Curve to Infinite Time (AUC [0-inf]) of MEDI6012
The area under the concentration-time curve to infinite time of MEDI6012.
Elimination Half Life (t1/2) of MEDI6012
The t1/2 is the time measured for the plasma concentration to decrease by one half.
Number of Participants With Positive Anti-Drug Antibodies for MEDI6012
Participants were tested for immunogenicity to MEDI6012. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of MEDI6012 to its target.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02601560
Brief Title
To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease
Official Title
A Phase 2a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single- Ascending Doses of MEDI6012 in Subjects With Stable Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 3, 2015 (Actual)
Primary Completion Date
August 20, 2016 (Actual)
Study Completion Date
November 3, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase 2a randomized, double-blind (subject/investigator blinded, MedImmune unblinded), placebo-controlled, dose-escalation study to evaluate the safety, PK/PD, and immunogenicity of single IV and SC MEDI6012 doses in adult subjects with stable CAD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, CAD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDI6012 24 mg IV
Arm Type
Experimental
Arm Description
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
Arm Title
MEDI6012 80 mg IV
Arm Type
Experimental
Arm Description
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
Arm Title
MEDI6012 240 mg IV
Arm Type
Experimental
Arm Description
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Arm Title
MEDI6012 800 mg IV
Arm Type
Experimental
Arm Description
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
Arm Title
MEDI6012 80 mg SC
Arm Type
Experimental
Arm Description
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
Arm Title
Placebo Intravenous (IV)
Arm Type
Placebo Comparator
Arm Description
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
Arm Title
MEDI6012 600 mg SC
Arm Type
Experimental
Arm Description
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Arm Title
Placebo Subcutaneous (SC)
Arm Type
Placebo Comparator
Arm Description
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
Intervention Type
Biological
Intervention Name(s)
MEDI6012
Intervention Description
Participants received a single IV (24, 80, 240, and 800 mg) and SC (80 and 600 mg) MEDI6012 doses on Day 1.
Intervention Type
Biological
Intervention Name(s)
Placebo SC
Intervention Description
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
Intervention Type
Biological
Intervention Name(s)
Placebo IV
Intervention Description
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Description
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame
Baseline (Day 1) up to Day 57
Title
Number of Participants With TEAEs Related to Electrocardiogram (ECG) Evaluations
Description
TEAEs observed in participants with clinically significant ECG abnormalities were assessed. TEAEs are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame
Baseline (Day 1) up to Day 57
Title
Number of Participants With TEAEs Related to Vital Sign Parameters
Description
TEAEs observed in participants with clinically significant vital signs abnormalities were assessed. Vital signs parameters included blood pressure, respiration rate, pulse, pulse oximetry, and body temperature.
Time Frame
Baseline (Day 1) up to Day 57
Title
Number of Participants With TEAEs Related to Clinical Laboratory Evaluations
Description
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Time Frame
Baseline (Day 1) up to Day 57
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hours (Hrs) (AUC [0-96 Hrs]) for High-Density Lipoprotein-Cholesterol (HDL-C)
Description
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of HDL-C.
Time Frame
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion, 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Secondary Outcome Measure Information:
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Total Cholesterol
Description
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of total cholesterol.
Time Frame
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Free Cholesterol
Description
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of free cholesterol.
Time Frame
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Cholesteryl Ester
Description
The AUC(0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of cholesteryl ester.
Time Frame
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Cholesteryl Ester
Description
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of high density lipoprotein cholesteryl ester.
Time Frame
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesterol
Description
The AUC(0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein cholesterol.
Time Frame
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Unesterified Cholesterol
Description
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of high density lipoprotein unesterified cholesterol.
Time Frame
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesteryl Ester
Description
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein cholesteryl ester.
Time Frame
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Unesterified Cholesterol
Description
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein unesterified cholesterol.
Time Frame
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Low Density Lipoprotein-Cholesterol (Direct)
Description
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of low density lipoprotein cholesterol (direct).
Time Frame
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) Post Dose for Apolipoprotein B
Description
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of apolipoprotein B.
Time Frame
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Title
Change From Baseline in Serum Concentration of Pre Beta 1-High Density Lipoprotein at Day 29
Description
The change from baseline in serum concentration of pre beta 1-high density lipoprotein was estimated.
Time Frame
Baseline (Day 1) and Day 29
Title
Change From Baseline in Serum Concentration of Lecithin-Cholesterol Acyltransferase (LCAT) at Day 57
Description
The change from baseline in serum concentration of lecithin-cholesterol acyltransferase was estimated.
Time Frame
Baseline (Day 1) and Day 57
Title
Maximum Observed Serum Concentration (Cmax) of MEDI6012
Description
The first occurrence of the maximum observed plasma concentration of MEDI6012 determined directly from the raw concentration time data.
Time Frame
Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)
Title
Time to Reach Concentration Maximum (Tmax) of MEDI6012
Description
The time at which Cmax of MEDI6012 was observed determined directly from raw concentration time data.
Time Frame
Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)
Title
Area Under the Concentration Time Curve From 0 to 168 Hrs (AUC [0-168]) of MEDI6012
Description
The area under the concentration-time curve from 0 to 168 hrs of MEDI6012.
Time Frame
Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)
Title
Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Concentration (AUC [0-last]) of MEDI6012
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUC [0-last]) of MEDI6012.
Time Frame
Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)
Title
Area Under the Concentration Time Curve to Infinite Time (AUC [0-inf]) of MEDI6012
Description
The area under the concentration-time curve to infinite time of MEDI6012.
Time Frame
Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)
Title
Elimination Half Life (t1/2) of MEDI6012
Description
The t1/2 is the time measured for the plasma concentration to decrease by one half.
Time Frame
Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)
Title
Number of Participants With Positive Anti-Drug Antibodies for MEDI6012
Description
Participants were tested for immunogenicity to MEDI6012. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of MEDI6012 to its target.
Time Frame
Day 1 (pre-dose), 15, 29 and 57
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women 40 - 75 years old
History of Stable CAD
Currently receiving statin as standard of care
Exclusion Criteria:
Severe angina pectoris symptoms
High-risk coronary or carotid artery disease that will likely require surgical or percutaneous intervention during the study period
Hospitalization for heart failure within 12 months prior to screening
Uncontrolled Hypertension
Within 6 months prior to screening, a history of ACS or hospitalization for heart failure
Clinically significant abnormalities in rhythm, conduction or morphology of ECG
Subjects with transplanted heart, left ventricular assist device, implanted pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy
Untreated life-threatening ventricular arrhythmias
History, within 12 months prior to screening, of myocarditis or restrictive pericarditis, or hemodynamically significant valvular hear disease or aortic disease
Undergone major surgery with in 3 months prior to screening or has planned major surgery during the study period
Facility Information:
Facility Name
Research Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Research Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34121413
Citation
George RT, Abuhatzira L, Stoughton SM, Karathanasis SK, She D, Jin C, Buss NAPS, Bakker-Arkema R, Ongstad EL, Koren M, Hirshberg B. MEDI6012: Recombinant Human Lecithin Cholesterol Acyltransferase, High-Density Lipoprotein, and Low-Density Lipoprotein Receptor-Mediated Reverse Cholesterol Transport. J Am Heart Assoc. 2021 Jul 6;10(13):e014572. doi: 10.1161/JAHA.119.014572. Epub 2021 Jun 14.
Results Reference
derived
Learn more about this trial
To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease
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