Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease
Condition: Atherosclerosis; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis
Intervention: MEDI6012 40 mg; Placebo; MEDI6012 120 mg; MEDI6012 300 mg; Placebo IV Push; MEDI6012 IV Push
Intervention description: Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.; Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.; Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.; Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.; 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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 60 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Atherosclerosis; Cardiovascular Disease; CAD; Atherosclerotic Cardiovascular Disease

Summary:

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

Eligibility 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.