Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MedImmune LLC
A Phase 2a Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of MEDI6012 in Subjects with Stable Atherosclerotic Cardiovascular Disease
Age
60–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Non-childbearing potential
Diagnosis of stable atherosclerotic CVD
Currently receiving a stable dose of Statin
You may not be 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.
Clareo Health | Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease
