Phase 2
N=48
To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02601560 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) — 3; 2; 5; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MEDI6012 (Biological); Placebo SC (Biological); Placebo IV (Biological)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
3; 2; 5; 2; 4; 2 | — |
| PRIMARY Number of Participants With TEAEs Related to Electrocardiogram (ECG) Evaluations |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With TEAEs Related to Vital Sign Parameters |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With TEAEs Related to Clinical Laboratory Evaluations |
0; 0; 0; 0; 0; 0 | — |
| 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) |
-49.1; 728.3; 1639.9; 3035.0; 5318.3; -113.5 | 0.095 |
| SECONDARY Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Total Cholesterol |
13.8; -164.9; 1925.7; 3639.2; 6990.3; 82.3 | — |
| SECONDARY Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Free Cholesterol |
38.4; -197.7; 38.9; 110.0; 434.6; 172.5 | — |
| SECONDARY Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Cholesteryl Ester |
-24.6; 32.8; 1886.8; 3529.2; 6555.7; -90.2 | — |
| SECONDARY Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Cholesteryl Ester |
-50.3; 668.4; 1460.7; 2778.0; 4886.0; -132.6 | — |
| SECONDARY Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesterol |
63.0; -893.2; 285.8; 604.2; 1672.0; 195.8 | — |
| SECONDARY Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Unesterified Cholesterol |
1.2; 59.9; 179.2; 248.4; 417.1; 19.1 | — |
| SECONDARY Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesteryl Ester |
25.8; -635.6; 426.1; 741.6; 1649.5; 42.4 | — |
| SECONDARY Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Unesterified Cholesterol |
37.2; -257.6; -140.3; -132.2; 27.8; 153.4 | — |
| SECONDARY Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Low Density Lipoprotein-Cholesterol (Direct) |
182.1; -473.0; 83.2; 987.2; 1812.8; -101.6 | — |
| SECONDARY Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) Post Dose for Apolipoprotein B |
220.7; -795.5; -636.7; -649.5; -537.1; 97.4 | — |
| SECONDARY Change From Baseline in Serum Concentration of Pre Beta 1-High Density Lipoprotein at Day 29 |
3.68; 1.75; 2.08; 2.53; 4.85; 3.90 | — |
| SECONDARY Change From Baseline in Serum Concentration of Lecithin-Cholesterol Acyltransferase (LCAT) at Day 57 |
1250.0; 1250.0; 1250.0; 1250.0; 1250.0; 1250.0 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of MEDI6012 |
5.02; 20.2; 73.5; 229; 22.8 | — |
| SECONDARY Time to Reach Concentration Maximum (Tmax) of MEDI6012 |
1.00; 1.00; 1.00; 1.00; 48.0 | — |
| SECONDARY Area Under the Concentration Time Curve From 0 to 168 Hrs (AUC [0-168]) of MEDI6012 |
137; 805; 2760; 8470; 2460 | — |
| SECONDARY Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Concentration (AUC [0-last]) of MEDI6012 |
46.8; 683; 2760; 9020; 2460 | — |
| SECONDARY Area Under the Concentration Time Curve to Infinite Time (AUC [0-inf]) of MEDI6012 |
137; 887; 3030; 9510; 3560 | — |
| SECONDARY Elimination Half Life (t1/2) of MEDI6012 |
17.6; 46.9; 45.7; 55.4; 89.5 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibodies for MEDI6012 |
0; 0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Men and women 40 - 75 years old
- History of Stable CAD
- Currently receiving statin as standard of care
Exclusion Criteria
- Severe angina pectoris symptoms
- High-risk coronary or carotid artery disease that will likely require surgical or percutaneous intervention during the study period
- Hospitalization for heart failure within 12 months prior to screening
- Uncontrolled Hypertension
- Within 6 months prior to screening, a history of ACS or hospitalization for heart failure
- Clinically significant abnormalities in rhythm, conduction or morphology of ECG
- Subjects with transplanted heart, left ventricular assist device, implanted pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy
- Untreated life-threatening ventricular arrhythmias
- History, within 12 months prior to screening, of myocarditis or restrictive pericarditis, or hemodynamically significant valvular hear disease or aortic disease
- Undergone major surgery with in 3 months prior to screening or has planned major surgery during the study period
Data sourced from ClinicalTrials.gov (NCT02601560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.