Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease
Completed · Phase 2 · Has a placebo group
Conditions studied: Atherosclerosis, Cardiovascular Disease
In brief
To evaluate the safety pharmacokinetics, and pharmacodynamics of repeat weekly dosing of MEDI6012 in subjects with stable atherosclerosis.
Key facts
- Study ID
- NCT03004638
- Run by
- MedImmune LLC
- People needed
- 32
- Starts
- 2017-01-23
- Expected to finish
- 2017-11-02
- Last updated by the study team
- 2018-12-19
Who can join
Age: 60 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Non-childbearing potential
- Diagnosis of stable atherosclerotic CVD
- Currently receiving a stable dose of Statin
You may not qualify if…
- Unstable cardiovascular condition within 3 months of screening
- Elective arterial revascularization with in the past month
- Any planned arterial revascularization
- Body mass index <18 or >45
- Clinically significant ECG that may interfere with the interpretation of serial ECG and QT interval changes at screening
- Chronic kidney disease defined by estimated glomerular filtration rate of less than 30 mL/mim/1.73m2
- Triglycerides greater than 500 mg/dL, LDL-C greater than 160 mg/dL, or HDL-C greater than 60 for males, or 65 for females
- Clinically significant vital sign abnormalities
- Genetic disorder of cholesterol metabolism
- History of overt liver disease
- Poorly controlled endocrine disorder (Diabetes or Thyroid disorder)
- Current or recent use of systemic corticosteroids
- Recent or ongoing infection or febrile illness
- History of active malignancy within 5 years
- History of alcohol or recreational substance abuse in the past 6 months
- Concurrent enrollment in another clinical study of any investigational drug therapy or use of any biologicals within 6 months prior to screening or within 5 half-lives of an investigational agent or biologic, whichever is longer.
Where it is running
- Research Site — Anniston, Alabama, United States
- Research Site — Jacksonville, Florida, United States
- Research Site — Port Orange, Florida, United States
- Research Site — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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