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

MedImmune

Status and phase: Completed; Phase 2

Conditions: Atherosclerosis; Cardiovascular Disease

Treatments: Drug: MEDI6012 40 mg; Drug: MEDI6012 300 mg; Drug: MEDI6012 120 mg; Drug: Placebo; Drug: Placebo IV Push; Drug: MEDI6012 IV Push

Study type: Interventional

Funder types: Industry

Identifiers

NCT03004638

D5780C00005

Details and patient eligibility

About

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

Full description

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

Enrollment: 32 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

32 participants in 6 patient groups, including a placebo group

MEDI6012 40 mg

Experimental group

Description:

Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.

Treatment:

Drug: MEDI6012 40 mg

Placebo

Placebo Comparator group

Description:

Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.

Treatment:

Drug: Placebo

MEDI6012 120 mg

Experimental group

Description:

Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.

Treatment:

Drug: MEDI6012 120 mg

MEDI6012 300 mg

Experimental group

Description:

Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.

Treatment:

Drug: MEDI6012 300 mg

MEDI6012 IV Push

Experimental group

Description:

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.

Treatment:

Drug: MEDI6012 IV Push

Placebo IV Push

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo IV Push