Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease

• Status: Completed
• Trial end date: 2017-11-02
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety pharmacokinetics, and pharmacodynamics of repeat weekly dosing of MEDI6012 in subjects with stable atherosclerosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC

Criteria

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 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.