| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03004638 | Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease | PHASE2 | COMPLETED | 32 | — | — | Jan 23, 2017 | Nov 2, 2017 | Dec 19, 2018 | 4 | United States |
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 56 days after last dose of study drug (Day 66 for Cohort 4 and placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm) that were absent before treatment or that worsened relative to pre-treatment state.
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis.
Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, respiration rate, heart rate, pulse oximetry, and body temperature.
Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported.
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol.
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol ester.
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of cholesterol ester.
| Arm | Type | Description |
|---|---|---|
| MEDI6012 40 mg | EXPERIMENTAL | Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15. |
| Placebo | PLACEBO_COMPARATOR | Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15. |
| MEDI6012 120 mg | EXPERIMENTAL | Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15. |
| MEDI6012 300 mg | EXPERIMENTAL | Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15. |
| MEDI6012 IV Push | EXPERIMENTAL | Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively. |
| Placebo IV Push | PLACEBO_COMPARATOR | Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10. |
| Name | Type | Description |
|---|---|---|
| MEDI6012 40 mg | DRUG | Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15. |
| Placebo | DRUG | Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15. |
| MEDI6012 120 mg | DRUG | Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15. |
| MEDI6012 300 mg | DRUG | Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15. |
| Placebo IV Push | DRUG | Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10. |
| MEDI6012 IV Push | DRUG | Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively. |
Inclusion Criteria: * Non-childbearing potential * Diagnosis of stable atherosclerotic CVD * Currently receiving a stable dose of Statin Exclusion Criteria: * Unstable cardiovascular condition within 3 months of screening * Elective arterial revascularization with in the past month * Any planned ...