Clinical trial NCT03004638
Conditions: Atherosclerosis Cardiovascular Disease
Keywords: Atherosclerosis Cardiovascular Disease CAD Atherosclerotic Cardiovascular Disease
Sponsor: MedImmune LLC
Start date: 2017-01-23; Completion date: 2017-11-02
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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

Detailed 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

Arms: arm 1: Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15. arm 2: Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15. arm 3: Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15. arm 4: Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15. arm 5: 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. arm 6: 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.
Interventions: intervention 1: MEDI6012 40 mg intervention 2: Placebo intervention 3: MEDI6012 120 mg intervention 4: MEDI6012 300 mg intervention 5: Placebo IV Push intervention 6: MEDI6012 IV Push
Intervention descriptions: intervention 1: Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15. intervention 2: Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15. intervention 3: Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15. intervention 4: Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15. intervention 5: 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. intervention 6: 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.

Protocol documents:
Prot_000.pdf: 
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