Multiple Ascending Doses of MEDI6012 in Subjects with Stable Atherosclerotic Cardiovascular Disease
Study identifier:D5780C00005
ClinicalTrials.gov identifier:NCT03004638
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Atherosclerosis
Phase
Phase 2
Healthy volunteers
No
Study drug
MEDI6012 40 mg, Placebo, MEDI6012 120 mg, MEDI6012 300 mg, Placebo IV Push, MEDI6012 IV Push
Sex
All
Actual Enrollment
32
Study type
Interventional
Age
60 Years - 80 Years
Date
Study Start Date: 23 Jan 2017
Primary Completion Date: 02 Nov 2017
Study Completion Date: 02 Nov 2017
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2018 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEDI6012 40 mg Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15. | Drug: MEDI6012 40 mg Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15. Other Name: None |
| Placebo Comparator: Placebo Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15. | Drug: Placebo Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15. Other Name: None |
| Experimental: MEDI6012 120 mg Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15. | Drug: MEDI6012 120 mg Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15. Other Name: None |
| Experimental: MEDI6012 300 mg Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15. | Drug: MEDI6012 300 mg Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15. Other Name: None |
| Experimental: MEDI6012 IV Push 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. | Drug: MEDI6012 IV Push 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. Other Name: None |
| Placebo Comparator: Placebo IV Push 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. | Drug: Placebo IV Push 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. Other Name: None |
