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CompletedNCT02601560Updated Mar 19, 2018Results posted

To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease

A Phase 2 interventional study of MEDI6012 and Placebo SC in Coronary Artery Disease, sponsored by MedImmune LLC. Completed at 8 sites in United States. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-03-19.

Sponsored by MedImmune LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Coronary Artery Disease
  • CAD
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 48 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Men and women 40 - 75 years old
  • History of Stable CAD
  • Currently receiving statin as standard of care

Exclusion criteria

Exclusion Criteria:

  • Severe angina pectoris symptoms
  • High-risk coronary or carotid artery disease that will likely require surgical or percutaneous intervention during the study period
  • Hospitalization for heart failure within 12 months prior to screening
  • Uncontrolled Hypertension
  • Within 6 months prior to screening, a history of ACS or hospitalization for heart failure
  • Clinically significant abnormalities in rhythm, conduction or morphology of ECG
  • Subjects with transplanted heart, left ventricular assist device, implanted pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy
  • Untreated life-threatening ventricular arrhythmias
  • History, within 12 months prior to screening, of myocarditis or restrictive pericarditis, or hemodynamically significant valvular hear disease or aortic disease
  • Undergone major surgery with in 3 months prior to screening or has planned major surgery during the study period
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    MEDI6012 24 mg IV

    Participants received a single IV dose of 24 mg MEDI6012 on Day 1.

    Biological: MEDI6012

  • Experimental
    MEDI6012 80 mg IV

    Participants received a single IV dose of 80 mg MEDI6012 on Day 1.

    Biological: MEDI6012

  • Experimental
    MEDI6012 240 mg IV

    Participants received a single IV dose of 240 mg MEDI6012 on Day 1.

    Biological: MEDI6012

  • Experimental
    MEDI6012 800 mg IV

    Participants received a single IV dose of 800 mg MEDI6012 on Day 1.

    Biological: MEDI6012

  • Experimental
    MEDI6012 80 mg SC

    Participants received a single SC dose of 80 mg MEDI6012 on Day 1.

    Biological: MEDI6012

  • Placebo comparator
    Placebo Intravenous (IV)

    Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.

    Biological: Placebo IV

  • Experimental
    MEDI6012 600 mg SC

    Participants received a single SC dose of 600 mg MEDI6012 on Day 1.

    Biological: MEDI6012

  • Placebo comparator
    Placebo Subcutaneous (SC)

    Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.

    Biological: Placebo SC

Interventions

  • BiologicalMEDI6012

    Participants received a single IV (24, 80, 240, and 800 mg) and SC (80 and 600 mg) MEDI6012 doses on Day 1.

  • BiologicalPlacebo SC

    Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.

  • BiologicalPlacebo IV

    Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (Day 1) up to Day 57

  2. 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.

    Time frame: Baseline (Day 1) up to Day 57

  3. 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.

    Time frame: Baseline (Day 1) up to Day 57

  4. 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.

    Time frame: Baseline (Day 1) up to Day 57

  5. 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.

    Time frame: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion, 4 and 8 hrs post-dose Day 1 (IV cohorts only)

Secondary outcomes

  1. 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.

    Time frame: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)

  2. 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.

    Time frame: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)

  3. 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.

    Time frame: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)

  4. 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.

    Time frame: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)

  5. 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.

    Time frame: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)

  6. 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.

    Time frame: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)

  7. 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.

    Time frame: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)

  8. 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.

    Time frame: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)

  9. 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).

    Time frame: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)

  10. 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.

    Time frame: Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)

  11. 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.

    Time frame: Baseline (Day 1) and Day 29

  12. 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.

    Time frame: Baseline (Day 1) and Day 57

  13. Maximum Observed Serum Concentration (Cmax) of MEDI6012

    The first occurrence of the maximum observed plasma concentration of MEDI6012 determined directly from the raw concentration time data.

    Time frame: Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)

  14. Time to Reach Concentration Maximum (Tmax) of MEDI6012

    The time at which Cmax of MEDI6012 was observed determined directly from raw concentration time data.

    Time frame: Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)

  15. 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.

    Time frame: Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)

  16. 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.

    Time frame: Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)

  17. 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.

    Time frame: Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)

  18. Elimination Half Life (t1/2) of MEDI6012

    The t1/2 is the time measured for the plasma concentration to decrease by one half.

    Time frame: Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)

  19. 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.

    Time frame: Day 1 (pre-dose), 15, 29 and 57

07

Results

Posted Mar 19, 2018

Participant flow

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.

Participant flow — Overall Study
MilestonePlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Started86666466
Completed86666456
Not completed00000010
Withdrew: Other00000010

Outcome measures

PrimaryNumber 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.

Time frame:
Baseline (Day 1) up to Day 57
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
ParticipantsPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
TEAEs32524234
TESAEs00000000
PrimaryNumber 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.

Time frame:
Baseline (Day 1) up to Day 57
Reported as:
Count of participants · Participants
Number of Participants With TEAEs Related to Electrocardiogram (ECG) Evaluations
ParticipantsPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Number of Participants With TEAEs Related to Electrocardiogram (ECG) Evaluations00000000
PrimaryNumber 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.

Time frame:
Baseline (Day 1) up to Day 57
Reported as:
Count of participants · Participants
Number of Participants With TEAEs Related to Vital Sign Parameters
ParticipantsPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Number of Participants With TEAEs Related to Vital Sign Parameters00000000
PrimaryNumber 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.

Time frame:
Baseline (Day 1) up to Day 57
Reported as:
Count of participants · Participants
Number of Participants With TEAEs Related to Clinical Laboratory Evaluations
ParticipantsPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Number of Participants With TEAEs Related to Clinical Laboratory Evaluations00000010
PrimaryBaseline-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.

Time frame:
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion, 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Reported as:
Mean · milligrams per deciliter (mg/dL)
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hours (Hrs) (AUC [0-96 Hrs]) for High-Density Lipoprotein-Cholesterol (HDL-C)
milligrams per deciliter (mg/dL)Placebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hours (Hrs) (AUC [0-96 Hrs]) for High-Density Lipoprotein-Cholesterol (HDL-C)-49.1 ± 120.0728.3 ± 334.21639.9 ± 631.73035.0 ± 439.15318.3 ± 1674.3-113.5 ± 289.4422.4 ± 395.72844.7 ± 1219.1
Statistical analysis
  • Placebo Intravenous (IV) vs MEDI6012 24 Milligram (mg) IV · ANCOVA · p = 0.095
  • Placebo Intravenous (IV) vs MEDI6012 80 mg IV · ANCOVA · p = <0.001
  • Placebo Intravenous (IV) vs MEDI6012 240 mg IV · ANCOVA · p = <0.001
  • Placebo Intravenous (IV) vs MEDI6012 800 mg IV · ANCOVA · p = <0.001
  • Placebo Subcutaneous (SC) vs MEDI6012 600 mg SC · ANCOVA · p = 0.440
  • Placebo Subcutaneous (SC) vs MEDI6012 80 mg SC · ANCOVA · p = <0.001
SecondaryBaseline-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.

Time frame:
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Reported as:
Mean · mg/dL
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Total Cholesterol
mg/dLPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Total Cholesterol13.8 ± 954.1-164.9 ± 1301.51925.7 ± 913.33639.2 ± 667.66990.3 ± 1764.082.3 ± 983.4240.9 ± 494.23156.8 ± 1476.5
SecondaryBaseline-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.

Time frame:
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Reported as:
Mean · mg/dL
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Free Cholesterol
mg/dLPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Free Cholesterol38.4 ± 265.4-197.7 ± 338.238.9 ± 346.8110.0 ± 133.9434.6 ± 541.7172.5 ± 76.6-61.5 ± 206.6-205.4 ± 324.5
SecondaryBaseline-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.

Time frame:
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Reported as:
Mean · mg/dL
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Cholesteryl Ester
mg/dLPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Cholesteryl Ester-24.6 ± 776.032.8 ± 992.61886.8 ± 722.83529.2 ± 628.36555.7 ± 1674.0-90.2 ± 965.4302.4 ± 428.43362.3 ± 1340.5
SecondaryBaseline-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.

Time frame:
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Reported as:
Mean · mg/dL
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Cholesteryl Ester
mg/dLPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Cholesteryl Ester-50.3 ± 108.9668.4 ± 263.31460.7 ± 584.02778.0 ± 416.74886.0 ± 1459.7-132.6 ± 253.1392.7 ± 350.32672.5 ± 1115.7
SecondaryBaseline-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.

Time frame:
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Reported as:
Mean · mg/dL
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesterol
mg/dLPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesterol63.0 ± 906.4-893.2 ± 1316.0285.8 ± 1051.8604.2 ± 659.11672.0 ± 1413.4195.8 ± 809.9-181.5 ± 385.1312.2 ± 642.4
SecondaryBaseline-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.

Time frame:
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Reported as:
Mean · mg/dL
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Unesterified Cholesterol
mg/dLPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Unesterified Cholesterol1.2 ± 38.059.9 ± 78.9179.2 ± 116.5248.4 ± 37.6417.1 ± 256.119.1 ± 46.629.7 ± 77.5172.2 ± 156.6
SecondaryBaseline-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.

Time frame:
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Reported as:
Mean · mg/dL
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesteryl Ester
mg/dLPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesteryl Ester25.8 ± 748.1-635.6 ± 984.0426.1 ± 723.0741.6 ± 590.51649.5 ± 1007.542.4 ± 791.6-90.3 ± 390.6689.8 ± 634.5
SecondaryBaseline-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.

Time frame:
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Reported as:
Mean · mg/dL
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Unesterified Cholesterol
mg/dLPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Unesterified Cholesterol37.2 ± 241.2-257.6 ± 351.8-140.3 ± 354.7-132.2 ± 139.927.8 ± 609.9153.4 ± 72.9-91.2 ± 155.2-377.6 ± 280.7
SecondaryBaseline-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).

Time frame:
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Reported as:
Mean · mg/dL
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Low Density Lipoprotein-Cholesterol (Direct)
mg/dLPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Low Density Lipoprotein-Cholesterol (Direct)182.1 ± 600.9-473.0 ± 1096.483.2 ± 762.0987.2 ± 453.81812.8 ± 1081.8-101.6 ± 854.2-61.7 ± 438.1996.1 ± 803.5
SecondaryBaseline-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.

Time frame:
Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)
Reported as:
Mean · mg/dL
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) Post Dose for Apolipoprotein B
mg/dLPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) Post Dose for Apolipoprotein B220.7 ± 524.7-795.5 ± 695.5-636.7 ± 682.6-649.5 ± 208.6-537.1 ± 706.297.4 ± 483.2-309.0 ± 270.5-219.0 ± 630.7
SecondaryChange 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.

Time frame:
Baseline (Day 1) and Day 29
Reported as:
Mean · mg/dL
Change From Baseline in Serum Concentration of Pre Beta 1-High Density Lipoprotein at Day 29
mg/dLPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Baseline (Day 1)3.68 ± 2.241.75 ± 0.372.08 ± 1.192.53 ± 1.804.85 ± 4.013.90 ± NA3.38 ± 1.481.67 ± 0.46
Change at Day 29-0.20 ± 1.27-0.02 ± 0.840.13 ± 0.320.40 ± 0.62-1.12 ± 3.21-1.10 ± NA1.33 ± 1.440.10 ± 0.60
SecondaryChange 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.

Time frame:
Baseline (Day 1) and Day 57
Reported as:
Mean · mcg/mL
Change From Baseline in Serum Concentration of Lecithin-Cholesterol Acyltransferase (LCAT) at Day 57
mcg/mLMEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVMEDI6012 80 mg SCMEDI6012 600 mg SC
Baseline (Day 1)1250.0 ± 0.01250.0 ± 0.01250.0 ± 0.01250.0 ± 0.01250.0 ± 0.01250.0 ± 0.0
Change at Day 570.0 ± NA——0.0 ± 0.00.0 ± NA—
SecondaryMaximum Observed Serum Concentration (Cmax) of MEDI6012

The first occurrence of the maximum observed plasma concentration of MEDI6012 determined directly from the raw concentration time data.

Time frame:
Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)
Reported as:
Mean · micrograms/milliliter (mcg/mL)
Maximum Observed Serum Concentration (Cmax) of MEDI6012
micrograms/milliliter (mcg/mL)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVMEDI6012 600 mg SC
Maximum Observed Serum Concentration (Cmax) of MEDI60125.02 ± 2.2520.2 ± 4.1573.5 ± 9.40229 ± 55.422.8 ± 9.75
SecondaryTime to Reach Concentration Maximum (Tmax) of MEDI6012

The time at which Cmax of MEDI6012 was observed determined directly from raw concentration time data.

Time frame:
Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)
Reported as:
Median · hrs
Time to Reach Concentration Maximum (Tmax) of MEDI6012
hrsMEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVMEDI6012 600 mg SC
Time to Reach Concentration Maximum (Tmax) of MEDI60121.00 ± 2.251.00 ± 4.151.00 ± 9.401.00 ± 55.448.0 ± 9.75
SecondaryArea 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.

Time frame:
Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)
Reported as:
Mean · mcg*hr/mL
Area Under the Concentration Time Curve From 0 to 168 Hrs (AUC [0-168]) of MEDI6012
mcg*hr/mLMEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVMEDI6012 600 mg SC
Area Under the Concentration Time Curve From 0 to 168 Hrs (AUC [0-168]) of MEDI6012137 ± 55.0805 ± 2652760 ± 2498470 ± 20002460 ± 824
SecondaryArea 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.

Time frame:
Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)
Reported as:
Mean · mcg*hr/mL
Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Concentration (AUC [0-last]) of MEDI6012
mcg*hr/mLMEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVMEDI6012 600 mg SC
Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Concentration (AUC [0-last]) of MEDI601246.8 ± 42.7683 ± 2672760 ± 2499020 ± 27602460 ± 824
SecondaryArea 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.

Time frame:
Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)
Reported as:
Mean · mcg*hr/mL
Area Under the Concentration Time Curve to Infinite Time (AUC [0-inf]) of MEDI6012
mcg*hr/mLMEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVMEDI6012 600 mg SC
Area Under the Concentration Time Curve to Infinite Time (AUC [0-inf]) of MEDI6012137 ± 56.1887 ± 3083030 ± 2989510 ± 27203560 ± 732
SecondaryElimination Half Life (t1/2) of MEDI6012

The t1/2 is the time measured for the plasma concentration to decrease by one half.

Time frame:
Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)
Reported as:
Mean · hrs
Elimination Half Life (t1/2) of MEDI6012
hrsMEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVMEDI6012 600 mg SC
Elimination Half Life (t1/2) of MEDI601217.6 ± 5.4746.9 ± 17.645.7 ± 3.6755.4 ± 14.289.5 ± 46.7
SecondaryNumber 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.

Time frame:
Day 1 (pre-dose), 15, 29 and 57
Reported as:
Count of participants · Participants
Number of Participants With Positive Anti-Drug Antibodies for MEDI6012
ParticipantsPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
Day 1 (predose)00000000
Day 1500000001
Day 2900001010
Day 57—0——2—1—

Adverse events

Collected over Adverse events were collected from baseline (Day 1) throughout the treatment period and including the follow-up period (up to Day 57).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo Intravenous (IV)—0/8 (0%)3/8 (37.5%)
MEDI6012 24 Milligram (mg) IV—0/6 (0%)2/6 (33.3%)
MEDI6012 80 mg IV—0/6 (0%)5/6 (83.3%)
MEDI6012 240 mg IV—0/6 (0%)2/6 (33.3%)
MEDI6012 800 mg IV—0/6 (0%)4/6 (66.7%)
Placebo Subcutaneous (SC)—0/4 (0%)2/4 (50%)
MEDI6012 80 mg SC—0/6 (0%)3/6 (50%)
MEDI6012 600 mg SC—0/6 (0%)4/6 (66.7%)
Most frequent other events
Showing 10 of 42
Most frequent other events
EventPlacebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SC
NauseaGastrointestinal disorders0/80/61/60/60/62/40/60/6
Injection site erythemaGeneral disorders0/80/60/60/60/60/40/62/6
Injection site reactionGeneral disorders0/80/60/60/60/60/42/61/6
HeadacheNervous system disorders0/80/61/60/61/60/40/62/6
MigraineNervous system disorders0/80/60/60/60/61/40/60/6
Angina pectorisCardiac disorders0/80/60/60/60/60/40/61/6
VertigoEar and labyrinth disorders0/80/61/60/60/60/40/60/6
DiplopiaEye disorders0/80/61/60/60/60/40/60/6
Abdominal discomfortGastrointestinal disorders0/80/60/61/60/60/40/60/6
ConstipationGastrointestinal disorders0/80/60/60/60/60/41/61/6

Baseline characteristics

As-treated Population: All participants who received any amount of study drug were included in this population.

Age, Continuous
Age, Continuous(Years)Placebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SCTotal
Mean62.8 ± 6.559.8 ± 7.060.0 ± 6.463.5 ± 5.465.8 ± 8.262.0 ± 9.371.3 ± 3.466.5 ± 4.764.0 ± 6.9
Sex: Female, Male
Sex: Female, Male(Participants)Placebo Intravenous (IV)MEDI6012 24 Milligram (mg) IVMEDI6012 80 mg IVMEDI6012 240 mg IVMEDI6012 800 mg IVPlacebo Subcutaneous (SC)MEDI6012 80 mg SCMEDI6012 600 mg SCTotal
Female103211019
Male7634536539
08

Study locations

8 sites
  • Research Site
    Anniston, Alabama 36207, United States
  • Research Site
    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
09

References and documents

Publications

  • 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. PubMed 34121413 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02601560
Lead sponsor
MedImmune LLC
Responsible party
Sponsor
First posted
Nov 10, 2015
Start date
Dec 3, 2015
Primary completion
Aug 20, 2016
Completion
Nov 3, 2016
Results posted
Mar 19, 2018
Last update
Mar 19, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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