At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of stable atherosclerotic cardiovascular disease
- ✓Currently on a stable dose of statin therapy
- ✓Non-childbearing potential (female subjects of childbearing potential excluded)
- ✕Unstable cardiovascular condition within 3 months prior to screening
- ✕Elective arterial revascularization within the past month or any planned arterial revascularization
- ✕Body mass index <18 or >45
- ✕Chronic kidney disease with eGFR <30 mL/min/1.73m²
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating MEDI6012 40 mg, Placebo, and 4 other interventions for Atherosclerosis and Cardiovascular Disease. Completed, enrolled 32 participants across 4 sites.
Detailed Summary
To evaluate the safety pharmacokinetics, and pharmacodynamics of repeat weekly dosing of MEDI6012 in subjects with stable atherosclerosis.
Study Details
Timeline
Interventions
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.