Study identifier:D5780C00002
ClinicalTrials.gov identifier:NCT02601560
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 2a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single- Ascending Doses of MEDI6012 in Subjects with Stable Coronary Artery Disease
Coronary artery disease
Phase 2
No
-
All
48
Interventional
40 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Sequential Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2018 by MedImmune, LLC
MedImmune, LLC
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: MEDI6012 24 mg IV Participants received a single IV dose of 24 mg MEDI6012 on Day 1. | Biological/Vaccine: MEDI6012 Participants received a single IV (24, 80, 240, and 800 mg) and SC (80 and 600 mg) MEDI6012 doses on Day 1. |
Experimental: MEDI6012 80 mg IV Participants received a single IV dose of 80 mg MEDI6012 on Day 1. | Biological/Vaccine: MEDI6012 Participants received a single IV (24, 80, 240, and 800 mg) and SC (80 and 600 mg) MEDI6012 doses on Day 1. |
Experimental: MEDI6012 240 mg IV Participants received a single IV dose of 240 mg MEDI6012 on Day 1. | Biological/Vaccine: MEDI6012 Participants received a single IV (24, 80, 240, and 800 mg) and SC (80 and 600 mg) MEDI6012 doses on Day 1. |
Experimental: MEDI6012 800 mg IV Participants received a single IV dose of 800 mg MEDI6012 on Day 1. | Biological/Vaccine: MEDI6012 Participants received a single IV (24, 80, 240, and 800 mg) and SC (80 and 600 mg) MEDI6012 doses on Day 1. |
Experimental: MEDI6012 80 mg SC Participants received a single SC dose of 80 mg MEDI6012 on Day 1. | Biological/Vaccine: MEDI6012 Participants received a single IV (24, 80, 240, and 800 mg) and SC (80 and 600 mg) MEDI6012 doses on Day 1. |
Placebo Comparator: Placebo Intravenous (IV) Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study. | Biological/Vaccine: Placebo IV Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study. |
Experimental: MEDI6012 600 mg SC Participants received a single SC dose of 600 mg MEDI6012 on Day 1. | Biological/Vaccine: MEDI6012 Participants received a single IV (24, 80, 240, and 800 mg) and SC (80 and 600 mg) MEDI6012 doses on Day 1. |
Placebo Comparator: Placebo Subcutaneous (SC) Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study. | Biological/Vaccine: Placebo SC Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study. |