ST Elevation Myocardial Infarction
Conditions
Brief summary
This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy, safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult participants presenting with acute STEMI (ST segment elevation myocardial infarction). The study will enrol participants presenting with acute STEMI who are planned for primary percutaneous coronary intervention (pPCI). For all participants, an end of study CMR will be performed at 10-12 weeks (70-84 days following Dose 1). A subset of participants will also undergo an index and an end of study CTA.
Interventions
BIOLOGICALMEDI6012
MEDI6012
OTHERPlacebo
Placebo
Sponsors
The TIMI Study Group
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
In this study, the participant and sponsor staff will be blinded. Sites will be trained to keep the investigator blinded. However, due to the acute nature of the study, members of the research team and, possibly, the investigator may be unblinded.
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Acute STEMI (ST segment elevation myocardial infarction) diagnosed by ST elevation * Planned for primary PCI (percutaneous coronary intervention) * Men and women without child-bearing potential aged 30-80 years of age * Capable and willing to provide informed consent. * Capable of completing study visits
Exclusion criteria
* Fibrinolytic administration for index event * Known prior MI or prior coronary artery bypass graft (CABG) surgery * Known pre-existing cardiomyopathy * History of anaphylaxis * Suspected non-thrombotic etiology (ie, vasospasm, dissection, Takotsubo cardiomyopathy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Infarct Size | 70 to 84 days post Day 1 dose | Global infarct size expressed as a percentage of left ventricle (LV) mass measured on delayed-enhanced cardiovascular magnetic resonance (CMR) imaging in 10-12 weeks post myocardial infarction (MI) is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Non-calcified Plaque Volume (NCPV) in the Coronary Arteries in Cohort B | Day 1 dose (48 to 72 hours post Dose 1) through 70 to 84 days post Day 1 dose | Change in NCPV in the coronary arteries from index computed tomography angiography (CTA) to 10-12 weeks post-MI is reported. The index CTA was preferably to be performed between 48 to 72 hours post Dose 1 (could be done up to 5 days post Dose 1) but no earlier than 40 hours post Dose 1. Participants with creatinine clearance \>= 60 mL/min (Cockcroft Gault equation) within 6 hours underwent an index coronary CTA no earlier than 40 hours following the first dose. |
| Left Ventricular Mass by Late Gadolinium Enhancement (LGE) | 70 to 84 days post Day 1 dose | The left ventricular mass by LGE is reported. |
| Left Ventricular Mass by Cine Magnetic Resonance Imaging (MRI) | 70 to 84 days post Day 1 dose | The left ventricular mass by cine MRI is reported. |
| Left Ventricular End-diastolic and End-systolic Volume | 70 to 84 days post Day 1 dose | Left ventricular end-diastolic and end-systolic volume is reported. |
| Left Ventricular Ejection Fraction (LVEF) | 70 to 84 days post Day 1 dose | The LVEF measured by cine magnetic resonance imaging (MRI) at 10-12 weeks post-MI is reported. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Day 1 through Day 195 post Day 1 dose | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is 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. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. |
| Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass) | Pre- and post-dose on Days 1, 3, 17, and 31 | Serum concentration of MEDI6012 is reported. |
| Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012 | Predose on Day 1, Day 17, Day 31, 70 to 84 days, and on Day 195 post Day 1 dose | Number of participants with positive ADA titer to MEDI6012 are reported in 3 categories, ADA positive at any visit up to Day 70-84 follow-up visit, ADA positive with \> 30% decrease in HDL-C from baseline (on the same date) at any visit up to D70-84 FU V, and ADA positive and \> 30% decrease in HDL-C from baseline at Day 70-84 Follow-up Visit. |
| Left Ventricular End-diastolic and End-systolic Volume Index | 70 to 84 days post Day 1 dose | Left ventricular end-diastolic and end-systolic volume index is reported. |
Countries
Brazil, Czechia, Hungary, Israel, Netherlands, Poland, Russia, Slovakia, Spain, United Kingdom
Participant flow
Recruitment details
This study was conducted in 10 countries (Brazil, Czech Republic, Hungary, Israel, Netherlands, Poland, Russian Federation, Slovakia, Spain, and the United Kingdom).
Pre-assignment details
In total, 593 participants were randomized into the study and 575 participants were treated with the study drug.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A: Placebo Participants received placebo matched to MEDI6012 on Day 1 prior to primary percutaneous coronary intervention (pPCI) followed by a second inpatient dose on Day 3 by intravenous (IV) push. | 94 |
| Cohort A: MEDI6012 Participants received loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3 by IV push. | 185 |
| Cohort B: Placebo Participants received placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3, and outpatient maintenance doses on Days 10, 17, 24, and 31 by IV push. | 112 |
| Cohort B: MEDI6012 Participants received loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3, and outpatient maintenance doses of MEDI6012 100 mg on Days 10, 17, 24, and 31 by IV push. | 202 |
| Total | 593 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 2 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Overall Study | Other | 3 | 6 | 2 | 8 |
| Overall Study | Withdrawal by Subject | 3 | 5 | 2 | 0 |
Baseline characteristics
| Characteristic | Cohort A: Placebo | Cohort A: MEDI6012 | Cohort B: Placebo | Cohort B: MEDI6012 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 59.7 Years STANDARD_DEVIATION 10.3 | 59.9 Years STANDARD_DEVIATION 10.2 | 62.6 Years STANDARD_DEVIATION 10.8 | 59.9 Years STANDARD_DEVIATION 10 | 60.4 Years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 8 Participants | 2 Participants | 10 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 92 Participants | 177 Participants | 110 Participants | 192 Participants | 571 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 94 Participants | 182 Participants | 110 Participants | 194 Participants | 580 Participants |
| Sex: Female, Male Female | 20 Participants | 35 Participants | 27 Participants | 49 Participants | 131 Participants |
| Sex: Female, Male Male | 74 Participants | 150 Participants | 85 Participants | 153 Participants | 462 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 2 / 179 | 0 / 111 | 1 / 195 |
| other Total, other adverse events | 28 / 90 | 74 / 179 | 47 / 111 | 89 / 195 |
| serious Total, serious adverse events | 11 / 90 | 34 / 179 | 24 / 111 | 41 / 195 |
Outcome results
Primary
Global Infarct Size
Global infarct size expressed as a percentage of left ventricle (LV) mass measured on delayed-enhanced cardiovascular magnetic resonance (CMR) imaging in 10-12 weeks post myocardial infarction (MI) is reported.
Time frame: 70 to 84 days post Day 1 dose
Population: Primary efficacy analysis population included randomized participants with a Thrombolysis in Myocardial Infarction (TIMI) flow Grade 0-1 on initial angiography who received at least 2 doses of study drug and grouped according to assigned treatment. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort A: Placebo | Global Infarct Size | 5.453 Percentage of global infarct size |
| Cohort A: MEDI6012 | Global Infarct Size | 8.598 Percentage of global infarct size |
| Cohort B: Placebo | Global Infarct Size | 9.004 Percentage of global infarct size |
| Cohort B: MEDI6012 | Global Infarct Size | 7.819 Percentage of global infarct size |
Secondary
Change in Non-calcified Plaque Volume (NCPV) in the Coronary Arteries in Cohort B
Change in NCPV in the coronary arteries from index computed tomography angiography (CTA) to 10-12 weeks post-MI is reported. The index CTA was preferably to be performed between 48 to 72 hours post Dose 1 (could be done up to 5 days post Dose 1) but no earlier than 40 hours post Dose 1. Participants with creatinine clearance \>= 60 mL/min (Cockcroft Gault equation) within 6 hours underwent an index coronary CTA no earlier than 40 hours following the first dose.
Time frame: Day 1 dose (48 to 72 hours post Dose 1) through 70 to 84 days post Day 1 dose
Population: The CTA analysis population included randomized participants in the 6-dose regimen who received a full treatment course of study drug, were eligible, and had coronary CTA. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort A: Placebo | Change in Non-calcified Plaque Volume (NCPV) in the Coronary Arteries in Cohort B | 1.049 mm^3 |
| Cohort A: MEDI6012 | Change in Non-calcified Plaque Volume (NCPV) in the Coronary Arteries in Cohort B | 0.998 mm^3 |
Secondary
Left Ventricular Ejection Fraction (LVEF)
The LVEF measured by cine magnetic resonance imaging (MRI) at 10-12 weeks post-MI is reported.
Time frame: 70 to 84 days post Day 1 dose
Population: Primary efficacy analysis population included randomized participants with a TIMI flow Grade 0-1 on initial angiography who received at least 2 doses of study drug and grouped according to assigned treatment. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort A: Placebo | Left Ventricular Ejection Fraction (LVEF) | 47.626 Percentage of LVEF |
| Cohort A: MEDI6012 | Left Ventricular Ejection Fraction (LVEF) | 47.083 Percentage of LVEF |
| Cohort B: Placebo | Left Ventricular Ejection Fraction (LVEF) | 47.329 Percentage of LVEF |
| Cohort B: MEDI6012 | Left Ventricular Ejection Fraction (LVEF) | 49.722 Percentage of LVEF |
Secondary
Left Ventricular End-diastolic and End-systolic Volume
Left ventricular end-diastolic and end-systolic volume is reported.
Time frame: 70 to 84 days post Day 1 dose
Population: Primary efficacy analysis population included randomized participants with a TIMI flow Grade 0-1 on initial angiography who received at least 2 doses of study drug and grouped according to assigned treatment. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A: Placebo | Left Ventricular End-diastolic and End-systolic Volume | Left ventricular end-diastolic volume | 174.059 mL |
| Cohort A: Placebo | Left Ventricular End-diastolic and End-systolic Volume | Left ventricular end-systolic volume | 87.038 mL |
| Cohort A: MEDI6012 | Left Ventricular End-diastolic and End-systolic Volume | Left ventricular end-systolic volume | 89.594 mL |
| Cohort A: MEDI6012 | Left Ventricular End-diastolic and End-systolic Volume | Left ventricular end-diastolic volume | 176.523 mL |
| Cohort B: Placebo | Left Ventricular End-diastolic and End-systolic Volume | Left ventricular end-diastolic volume | 167.480 mL |
| Cohort B: Placebo | Left Ventricular End-diastolic and End-systolic Volume | Left ventricular end-systolic volume | 84.977 mL |
| Cohort B: MEDI6012 | Left Ventricular End-diastolic and End-systolic Volume | Left ventricular end-diastolic volume | 172.733 mL |
| Cohort B: MEDI6012 | Left Ventricular End-diastolic and End-systolic Volume | Left ventricular end-systolic volume | 83.676 mL |
Secondary
Left Ventricular End-diastolic and End-systolic Volume Index
Left ventricular end-diastolic and end-systolic volume index is reported.
Time frame: 70 to 84 days post Day 1 dose
Population: Primary efficacy analysis population included randomized participants with a TIMI flow Grade 0-1 on initial angiography who received at least 2 doses of study drug and grouped according to assigned treatment. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A: Placebo | Left Ventricular End-diastolic and End-systolic Volume Index | Left ventricular end-systolic volume index | 44.491 mL/m^2 |
| Cohort A: Placebo | Left Ventricular End-diastolic and End-systolic Volume Index | Left ventricular end-diastolic volume index | 89.158 mL/m^2 |
| Cohort A: MEDI6012 | Left Ventricular End-diastolic and End-systolic Volume Index | Left ventricular end-systolic volume index | 45.821 mL/m^2 |
| Cohort A: MEDI6012 | Left Ventricular End-diastolic and End-systolic Volume Index | Left ventricular end-diastolic volume index | 90.280 mL/m^2 |
| Cohort B: Placebo | Left Ventricular End-diastolic and End-systolic Volume Index | Left ventricular end-diastolic volume index | 86.118 mL/m^2 |
| Cohort B: Placebo | Left Ventricular End-diastolic and End-systolic Volume Index | Left ventricular end-systolic volume index | 43.695 mL/m^2 |
| Cohort B: MEDI6012 | Left Ventricular End-diastolic and End-systolic Volume Index | Left ventricular end-systolic volume index | 42.270 mL/m^2 |
| Cohort B: MEDI6012 | Left Ventricular End-diastolic and End-systolic Volume Index | Left ventricular end-diastolic volume index | 87.258 mL/m^2 |
Secondary
Left Ventricular Mass by Cine Magnetic Resonance Imaging (MRI)
The left ventricular mass by cine MRI is reported.
Time frame: 70 to 84 days post Day 1 dose
Population: Primary efficacy analysis population included randomized participants with a TIMI flow Grade 0-1 on initial angiography who received at least 2 doses of study drug and grouped according to assigned treatment. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo | Left Ventricular Mass by Cine Magnetic Resonance Imaging (MRI) | 113.953 g | Standard Deviation 31.261 |
| Cohort A: MEDI6012 | Left Ventricular Mass by Cine Magnetic Resonance Imaging (MRI) | 113.870 g | Standard Deviation 23.885 |
| Cohort B: Placebo | Left Ventricular Mass by Cine Magnetic Resonance Imaging (MRI) | 110.244 g | Standard Deviation 28.009 |
| Cohort B: MEDI6012 | Left Ventricular Mass by Cine Magnetic Resonance Imaging (MRI) | 111.533 g | Standard Deviation 23.329 |
Secondary
Left Ventricular Mass by Late Gadolinium Enhancement (LGE)
The left ventricular mass by LGE is reported.
Time frame: 70 to 84 days post Day 1 dose
Population: Primary efficacy analysis population included randomized participants with a TIMI flow Grade 0-1 on initial angiography who received at least 2 doses of study drug and grouped according to assigned treatment. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo | Left Ventricular Mass by Late Gadolinium Enhancement (LGE) | 119.740 g | Standard Deviation 31.384 |
| Cohort A: MEDI6012 | Left Ventricular Mass by Late Gadolinium Enhancement (LGE) | 119.581 g | Standard Deviation 23.949 |
| Cohort B: Placebo | Left Ventricular Mass by Late Gadolinium Enhancement (LGE) | 115.221 g | Standard Deviation 28.328 |
| Cohort B: MEDI6012 | Left Ventricular Mass by Late Gadolinium Enhancement (LGE) | 117.920 g | Standard Deviation 24.821 |
Secondary
Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012
Number of participants with positive ADA titer to MEDI6012 are reported in 3 categories, ADA positive at any visit up to Day 70-84 follow-up visit, ADA positive with \> 30% decrease in HDL-C from baseline (on the same date) at any visit up to D70-84 FU V, and ADA positive and \> 30% decrease in HDL-C from baseline at Day 70-84 Follow-up Visit.
Time frame: Predose on Day 1, Day 17, Day 31, 70 to 84 days, and on Day 195 post Day 1 dose
Population: Immunogenicity population included all treated participants, grouped according to actual treatment received and had at least one serum sample for immunogenicity testing.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Placebo | Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012 | ADA positive at any visit up to Day 70-84 Follow-up Visit | 1 Participants |
| Cohort A: Placebo | Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012 | ADA positive and > 30% decrease in HDL-C from baseline at Day 70-84 Follow-up Visit | 1 Participants |
| Cohort A: Placebo | Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012 | ADA positive and > 30% decrease in HDL-C from baseline at any visit up to Day 70-84 Follow-up Visit | 1 Participants |
| Cohort A: MEDI6012 | Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012 | ADA positive at any visit up to Day 70-84 Follow-up Visit | 13 Participants |
| Cohort A: MEDI6012 | Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012 | ADA positive and > 30% decrease in HDL-C from baseline at Day 70-84 Follow-up Visit | 0 Participants |
| Cohort A: MEDI6012 | Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012 | ADA positive and > 30% decrease in HDL-C from baseline at any visit up to Day 70-84 Follow-up Visit | 3 Participants |
| Cohort B: Placebo | Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012 | ADA positive and > 30% decrease in HDL-C from baseline at any visit up to Day 70-84 Follow-up Visit | 0 Participants |
| Cohort B: Placebo | Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012 | ADA positive at any visit up to Day 70-84 Follow-up Visit | 1 Participants |
| Cohort B: Placebo | Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012 | ADA positive and > 30% decrease in HDL-C from baseline at Day 70-84 Follow-up Visit | 0 Participants |
| Cohort B: MEDI6012 | Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012 | ADA positive at any visit up to Day 70-84 Follow-up Visit | 93 Participants |
| Cohort B: MEDI6012 | Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012 | ADA positive and > 30% decrease in HDL-C from baseline at Day 70-84 Follow-up Visit | 1 Participants |
| Cohort B: MEDI6012 | Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012 | ADA positive and > 30% decrease in HDL-C from baseline at any visit up to Day 70-84 Follow-up Visit | 1 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is 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. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time frame: Day 1 through Day 195 post Day 1 dose
Population: As-treated population included all treated participants, grouped according to actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 49 Participants |
| Cohort A: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 11 Participants |
| Cohort A: MEDI6012 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 34 Participants |
| Cohort A: MEDI6012 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 114 Participants |
| Cohort B: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 70 Participants |
| Cohort B: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 24 Participants |
| Cohort B: MEDI6012 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TEAEs | 136 Participants |
| Cohort B: MEDI6012 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Any TESAEs | 41 Participants |
Secondary
Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass)
Serum concentration of MEDI6012 is reported.
Time frame: Pre- and post-dose on Days 1, 3, 17, and 31
Population: Pharmacokinetic population included all participants in the As-treated population who had at least one detectable serum concentration measurement for LCAT mass or activity. 'Number analyzed' denotes participants who had adequate pharmacokinetic sample of MEDI6012 for the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Placebo | Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass) | Day 1 (pre-dose) | NA ng/mL | — |
| Cohort A: Placebo | Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass) | Day 1 (post-dose) | 76795.9 ng/mL | Standard Deviation 31136.7 |
| Cohort A: Placebo | Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass) | Day 3 (pre-dose) | 28017.9 ng/mL | Standard Deviation 11019.6 |
| Cohort A: Placebo | Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass) | Day 3 (post-dose) | 94653.8 ng/mL | Standard Deviation 115895.1 |
| Cohort A: MEDI6012 | Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass) | Day 31 (pre-dose) | 4954.8 ng/mL | Standard Deviation 4193.9 |
| Cohort A: MEDI6012 | Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass) | Day 3 (pre-dose) | 27738.8 ng/mL | Standard Deviation 12892.4 |
| Cohort A: MEDI6012 | Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass) | Day 31 (post-dose) | 67519.7 ng/mL | Standard Deviation 224677.3 |
| Cohort A: MEDI6012 | Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass) | Day 3 (post-dose) | 87663.1 ng/mL | Standard Deviation 93166.2 |
| Cohort A: MEDI6012 | Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass) | Day 17 (pre-dose) | 4509.9 ng/mL | Standard Deviation 2372.6 |
| Cohort A: MEDI6012 | Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass) | Day 1 (pre-dose) | NA ng/mL | — |
| Cohort A: MEDI6012 | Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass) | Day 17 (post-dose) | 49111.0 ng/mL | Standard Deviation 71552.1 |
| Cohort A: MEDI6012 | Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass) | Day 1 (post-dose) | 74661.2 ng/mL | Standard Deviation 24561.6 |