To Evaluate Safety, Pharmacokinetics and Pharmacodynamics... | NCT02601560 | Trialant
NCT02601560
Sponsor
MedImmune LLC
Status
Completed
Last Update Posted
Mar 19, 2018Actual
Enrollment
48Actual
Phase
Phase 2
Conditions
Coronary Artery Disease
Interventions
MEDI6012
Placebo SC
Placebo IV
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02601560
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D5780C00002
Secondary IDs
Not provided
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
Acronym
Not provided
Organization
MedImmune LLCINDUSTRY
Status Module
Record Verification Date
Mar 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 3, 2015Actual
Primary Completion Date
Aug 20, 2016Actual
Completion Date
Nov 3, 2016Actual
First Submitted Date
Nov 9, 2015
First Submission Date that Met QC Criteria
Nov 9, 2015
First Posted Date
Nov 10, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 8, 2017
Results First Submitted that Met QC Criteria
Mar 16, 2018
Results First Posted Date
Mar 19, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 1, 2017
Certification/Extension First Submitted that Passed QC Review
Aug 16, 2017
Certification/Extension First Posted Date
Aug 18, 2017Actual
Last Update Submitted Date
Mar 16, 2018
Last Update Posted Date
Mar 19, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MedImmune LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Coronary Artery Disease
Keywords
Coronary Artery Disease
CAD
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
48Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MEDI6012 24 mg IV
Experimental
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
Biological: MEDI6012
MEDI6012 80 mg IV
Experimental
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
Biological: MEDI6012
MEDI6012 240 mg IV
Experimental
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Biological: MEDI6012
MEDI6012 800 mg IV
Experimental
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
Biological: MEDI6012
MEDI6012 80 mg SC
Experimental
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
Biological: MEDI6012
Placebo Intravenous (IV)
Placebo Comparator
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MEDI6012
Biological
Participants received a single IV (24, 80, 240, and 800 mg) and SC (80 and 600 mg) MEDI6012 doses on Day 1.
MEDI6012 24 mg IV
MEDI6012 240 mg IV
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Baseline (Day 1) up to Day 57
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.
Baseline (Day 1) up to Day 57
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.
Baseline (Day 1) up to Day 57
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 (Day 1) up to Day 57
Secondary Outcomes
Measure
Description
Time Frame
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.
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)
Other Outcomes
Not provided
Eligibility Module
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
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
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Out of 230 participants, 182 participants were considered screen failures. The remaining 48 participants were randomized to receive the study drug. The 1600 mg dose was omitted based on a greater than expected pharmacodynamics effects at lower doses.
Recruitment Details
A total of 230 participants were screened in the study from 07-Dec-2015 to 13-Jan-2017 at 8 sites in the United States of America.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
FG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Biological: Placebo IV
MEDI6012 600 mg SC
Experimental
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Biological: MEDI6012
Placebo Subcutaneous (SC)
Placebo Comparator
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
Biological: Placebo SC
MEDI6012 600 mg SC
MEDI6012 80 mg IV
MEDI6012 80 mg SC
MEDI6012 800 mg IV
Placebo SC
Biological
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
Placebo Subcutaneous (SC)
Placebo IV
Biological
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
Placebo Intravenous (IV)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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).
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)
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.
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)
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.
Baseline (Day 1) and Day 29
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.
Baseline (Day 1) and Day 57
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.
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)
Time to Reach Concentration Maximum (Tmax) of MEDI6012
The time at which Cmax of MEDI6012 was observed determined directly from raw concentration time data.
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)
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.
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)
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.
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)
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.
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)
Elimination Half Life (t1/2) of MEDI6012
The t1/2 is the time measured for the plasma concentration to decrease by one half.
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)
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.
Day 1 (pre-dose), 15, 29 and 57
Jacksonville
Florida
32216
United States
Research Site
Port Orange
Florida
32127
United States
Research Site
Durham
North Carolina
27710
United States
Research Site
Raleigh
North Carolina
27612
United States
Research Site
Cincinnati
Ohio
45227
United States
Research Site
San Antonio
Texas
78229
United States
Research Site
Falls Church
Virginia
22042
United States
FG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
FG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
FG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
FG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
FG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
FG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
FG0008 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG0054 subjects
FG0066 subjects
FG0076 subjects
COMPLETED
FG0008 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG0054 subjects
FG0065 subjects
FG0076 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
As-treated Population: All participants who received any amount of study drug were included in this population.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
BG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
BG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
BG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
BG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
BG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
BG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
BG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0016
BG0026
BG0036
BG0046
BG0054
BG0066
BG0076
BG00848
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00062.8± 6.5
BG00159.8± 7.0
BG00260.0± 6.4
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
As-treated Population: All participants who received any amount of study drug were included in this population.
Posted
Count of Participants
Participants
Baseline (Day 1) up to Day 57
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
OG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG003
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0003
OG0012
OG0025
OG003
Primary
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.
As-treated Population
Posted
Count of Participants
Participants
Baseline (Day 1) up to Day 57
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Primary
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.
As-treated Population
Posted
Count of Participants
Participants
Baseline (Day 1) up to Day 57
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
OG004
Primary
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.
As-treated Population
Posted
Count of Participants
Participants
Baseline (Day 1) up to Day 57
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Primary
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.
As-treated Population.
Posted
Mean
Standard Deviation
milligrams per deciliter (mg/dL)
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)
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Secondary
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.
As-treated population
Posted
Mean
Standard Deviation
mg/dL
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)
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Secondary
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.
As-treated population
Posted
Mean
Standard Deviation
mg/dL
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)
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Secondary
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.
As-treated population
Posted
Mean
Standard Deviation
mg/dL
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)
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Secondary
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.
As-treated population
Posted
Mean
Standard Deviation
mg/dL
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)
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Secondary
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.
As-treated population
Posted
Mean
Standard Deviation
mg/dL
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)
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Secondary
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.
As-treated population
Posted
Mean
Standard Deviation
mg/dL
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)
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Secondary
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.
As-treated population
Posted
Mean
Standard Deviation
mg/dL
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)
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Secondary
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.
As-treated population
Posted
Mean
Standard Deviation
mg/dL
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)
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Secondary
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).
As-treated population
Posted
Mean
Standard Deviation
mg/dL
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)
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Secondary
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.
As-treated population
Posted
Mean
Standard Deviation
mg/dL
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)
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Secondary
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.
As-treated population.
Posted
Mean
Standard Deviation
mg/dL
Baseline (Day 1) and Day 29
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
OG004
MEDI6012 800 mg IV
Secondary
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.
Pharmacokinetic (PK) population: All participants in the as-treated population who had atleast one detectable LCAT serum concentration measurement.
Posted
Mean
Standard Deviation
mcg/mL
Baseline (Day 1) and Day 57
ID
Title
Description
OG000
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG001
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG002
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
OG003
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG004
Secondary
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.
PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).
Posted
Mean
Standard Deviation
micrograms/milliliter (mcg/mL)
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)
ID
Title
Description
OG000
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG001
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG002
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
OG003
MEDI6012 800 mg IV
Secondary
Time to Reach Concentration Maximum (Tmax) of MEDI6012
The time at which Cmax of MEDI6012 was observed determined directly from raw concentration time data.
PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).
Posted
Median
Full Range
hrs
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)
ID
Title
Description
OG000
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG001
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG002
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
OG003
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
Secondary
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.
PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).
Posted
Mean
Standard Deviation
mcg*hr/mL
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)
ID
Title
Description
OG000
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG001
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG002
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
OG003
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
Secondary
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.
PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).
Posted
Mean
Standard Deviation
mcg*hr/mL
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)
ID
Title
Description
OG000
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG001
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG002
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
OG003
MEDI6012 800 mg IV
Secondary
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.
PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).
Posted
Mean
Standard Deviation
mcg*hr/mL
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)
ID
Title
Description
OG000
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG001
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG002
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
OG003
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
Secondary
Elimination Half Life (t1/2) of MEDI6012
The t1/2 is the time measured for the plasma concentration to decrease by one half.
PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).
Posted
Mean
Standard Deviation
hrs
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)
ID
Title
Description
OG000
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG001
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG002
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
OG003
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
Secondary
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.
Immunogenicity population: All participants in the as-treated population with at least one serum sample available for immunogenicity testing.
Posted
Count of Participants
Participants
Day 1 (pre-dose), 15, 29 and 57
ID
Title
Description
OG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
OG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
OG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
OG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
Time Frame
Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo Intravenous (IV)
Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
0
8
3
8
EG001
MEDI6012 24 Milligram (mg) IV
Participants received a single IV dose of 24 mg MEDI6012 on Day 1.
0
6
2
6
EG002
MEDI6012 80 mg IV
Participants received a single IV dose of 80 mg MEDI6012 on Day 1.
0
6
5
6
EG003
MEDI6012 240 mg IV
Participants received a single IV dose of 240 mg MEDI6012 on Day 1.
0
6
2
6
EG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
0
6
4
6
EG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
0
4
2
4
EG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
0
6
3
6
EG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
0
6
4
6
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected6 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Diplopia
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Infusion site bruising
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Infusion site reaction
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site bruising
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site erythema
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site pain
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site reaction
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Medical device site irritation
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
High density lipoprotein decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory rate increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0023 events1 affected6 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Migraine
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Slow speech
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Microalbuminuria
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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Point of Contact
Title
Organization
Phone
Extension
Email
Richard George, MD, Director, Clinical Development
MedImmune, LLC
+1-301-398-5681
information.center@astrazeneca.com
ID
Term
D003324
Coronary Artery Disease
Ancestor Terms
ID
Term
D003327
Coronary Disease
D017202
Myocardial Ischemia
D006331
Heart Diseases
D002318
Cardiovascular Diseases
D001161
Arteriosclerosis
D001157
Arterial Occlusive Diseases
D014652
Vascular Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
63.5
± 5.4
BG00465.8± 8.2
BG00562.0± 9.3
BG00671.3± 3.4
BG00766.5± 4.7
BG00864.0± 6.9
3
BG0032
BG0041
BG0051
BG0060
BG0071
BG0089
Male
BG0007
BG0016
BG0023
BG0034
BG0045
BG0053
BG0066
BG0075
BG00839
6
OG0046
OG0054
OG0066
OG0076
2
OG0044
OG0052
OG0063
OG0074
TESAEs
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG0054
OG0066
OG0076
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG0054
OG0066
OG0076
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG0054
OG0066
OG0076
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG0054
OG0066
OG0076
Title
Denominators
Categories
Title
Measurements
OG000-49.1± 120.0
OG001728.3± 334.2
OG0021639.9± 631.7
OG0033035.0± 439.1
OG0045318.3± 1674.3
OG005-113.5± 289.4
OG006422.4± 395.7
OG0072844.7± 1219.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.095
Superiority or Other
OG000
OG002
ANCOVA
<0.001
Superiority or Other
OG000
OG003
ANCOVA
<0.001
Superiority or Other
OG000
OG004
ANCOVA
<0.001
Superiority or Other
OG005
OG007
ANCOVA
0.440
Superiority or Other
OG005
OG006
ANCOVA
<0.001
Superiority or Other
OG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG0054
OG0066
OG0076
Title
Denominators
Categories
Title
Measurements
OG00013.8± 954.1
OG001-164.9± 1301.5
OG0021925.7± 913.3
OG0033639.2± 667.6
OG0046990.3± 1764.0
OG00582.3± 983.4
OG006240.9± 494.2
OG0073156.8± 1476.5
OG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG0054
OG0066
OG0076
Title
Denominators
Categories
Title
Measurements
OG00038.4± 265.4
OG001-197.7± 338.2
OG00238.9± 346.8
OG003110.0± 133.9
OG004434.6± 541.7
OG005172.5± 76.6
OG006-61.5± 206.6
OG007-205.4± 324.5
OG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG0054
OG0066
OG0076
Title
Denominators
Categories
Title
Measurements
OG000-24.6± 776.0
OG00132.8± 992.6
OG0021886.8± 722.8
OG0033529.2± 628.3
OG0046555.7± 1674.0
OG005-90.2± 965.4
OG006302.4± 428.4
OG0073362.3± 1340.5
OG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG0054
OG0066
OG0076
Title
Denominators
Categories
Title
Measurements
OG000-50.3± 108.9
OG001668.4± 263.3
OG0021460.7± 584.0
OG0032778.0± 416.7
OG0044886.0± 1459.7
OG005-132.6± 253.1
OG006392.7± 350.3
OG0072672.5± 1115.7
OG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG0054
OG0066
OG0076
Title
Denominators
Categories
Title
Measurements
OG00063.0± 906.4
OG001-893.2± 1316.0
OG002285.8± 1051.8
OG003604.2± 659.1
OG0041672.0± 1413.4
OG005195.8± 809.9
OG006-181.5± 385.1
OG007312.2± 642.4
OG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG0054
OG0066
OG0076
Title
Denominators
Categories
Title
Measurements
OG0001.2± 38.0
OG00159.9± 78.9
OG002179.2± 116.5
OG003248.4± 37.6
OG004417.1± 256.1
OG00519.1± 46.6
OG00629.7± 77.5
OG007172.2± 156.6
OG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG0054
OG0066
OG0076
Title
Denominators
Categories
Title
Measurements
OG00025.8± 748.1
OG001-635.6± 984.0
OG002426.1± 723.0
OG003741.6± 590.5
OG0041649.5± 1007.5
OG00542.4± 791.6
OG006-90.3± 390.6
OG007689.8± 634.5
OG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG0054
OG0066
OG0076
Title
Denominators
Categories
Title
Measurements
OG00037.2± 241.2
OG001-257.6± 351.8
OG002-140.3± 354.7
OG003-132.2± 139.9
OG00427.8± 609.9
OG005153.4± 72.9
OG006-91.2± 155.2
OG007-377.6± 280.7
OG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG0054
OG0066
OG0076
Title
Denominators
Categories
Title
Measurements
OG000182.1± 600.9
OG001-473.0± 1096.4
OG00283.2± 762.0
OG003987.2± 453.8
OG0041812.8± 1081.8
OG005-101.6± 854.2
OG006-61.7± 438.1
OG007996.1± 803.5
OG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG0054
OG0066
OG0076
Title
Denominators
Categories
Title
Measurements
OG000220.7± 524.7
OG001-795.5± 695.5
OG002-636.7± 682.6
OG003-649.5± 208.6
OG004-537.1± 706.2
OG00597.4± 483.2
OG006-309.0± 270.5
OG007-219.0± 630.7
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG0054
OG0066
OG0076
Title
Denominators
Categories
Baseline (Day 1)
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0034
ParticipantsOG0046
ParticipantsOG0051
ParticipantsOG0065
ParticipantsOG0073
Title
Measurements
OG0003.68± 2.24
OG0011.75± 0.37
OG0022.08± 1.19
OG003
Change at Day 29
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0033
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG005
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0045
OG0056
Title
Denominators
Categories
Baseline (Day 1)
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0056
Title
Measurements
OG0001250.0± 0.0
OG0011250.0± 0.0
OG0021250.0± 0.0
OG003
Change at Day 57
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG004
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG0005.02± 2.25
OG00120.2± 4.15
OG00273.5± 9.40
OG003229± 55.4
OG00422.8± 9.75
OG004
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG0001.00± 2.25(1.00 to 1.00)
OG0011.00± 4.15(1.00 to 1.50)
OG0021.00± 9.40(1.00 to 2.00)
OG0031.00± 55.4(1.00 to 1.50)
OG00448.0± 9.75(48.0 to 72.0)
OG004
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG000137± 55.0
OG001805± 265
OG0022760± 249
OG0038470± 2000
OG0042460± 824
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG004
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG00046.8± 42.7(1.00 to 1.00)
OG001683± 267(1.00 to 1.50)
OG0022760± 249(1.00 to 2.00)
OG0039020± 2760(1.00 to 1.50)
OG0042460± 824(48.0 to 72.0)
OG004
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG000137± 56.1
OG001887± 308
OG0023030± 298
OG0039510± 2720
OG0043560± 732
OG004
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG00017.6± 5.47
OG00146.9± 17.6
OG00245.7± 3.67
OG00355.4± 14.2
OG00489.5± 46.7
OG004
MEDI6012 800 mg IV
Participants received a single IV dose of 800 mg MEDI6012 on Day 1.
OG005
Placebo Subcutaneous (SC)
Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
OG006
MEDI6012 80 mg SC
Participants received a single SC dose of 80 mg MEDI6012 on Day 1.
OG007
MEDI6012 600 mg SC
Participants received a single SC dose of 600 mg MEDI6012 on Day 1.
Units
Counts
Participants
OG0008
OG0016
OG0026
OG0036
OG0046
OG0054
OG0066
OG0076
Title
Denominators
Categories
Day 1 (predose)
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0054
ParticipantsOG0066
ParticipantsOG0076
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 15
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
Day 29
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0036
Day 57
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected6 at risk
EG0071 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0053 events2 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0072 events2 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected6 at risk
EG0071 events1 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0072 events2 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
2.53
± 1.80
OG0044.85± 4.01
OG0053.90± NAStandard deviation cannot be determined as only 1 participant was available.
OG0063.38± 1.48
OG0071.67± 0.46
Participants
OG004
6
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0073
Title
Measurements
OG000-0.20± 1.27
OG001-0.02± 0.84
OG0020.13± 0.32
OG0030.40± 0.62
OG004-1.12± 3.21
OG005-1.10± NAStandard deviation cannot be determined as only 1 participant was available.
OG0061.33± 1.44
OG0070.10± 0.60
1250.0
± 0.0
OG0041250.0± 0.0
OG0051250.0± 0.0
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0000.0± NAStandard deviation cannot be determined as only 1 participant was available.
OG0030.0± 0.0
OG0040.0± NAStandard deviation cannot be determined as only 1 participant was available.