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
-
This is a Phase 2a randomized, double-blind (subject/investigator blinded, MedImmune unblinded), placebo-controlled, dose-escalation study to evaluate the safety, PK/PD, and immunogenicity of single IV and SC MEDI6012 doses in adult subjects with stable CAD.
Location
Location
Cincinnati, OH, United States, 45227
Location
San Antonio, TX, United States, 78229
Location
Jacksonville, FL, United States, 32216
Location
Anniston, AL, United States, 36207
Location
Durham, NC, United States, 27710
Location
Raleigh, NC, United States, 27612
Location
Port Orange, FL, United States, 32127
Location
Falls Church, VA, United States, 22042
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. |
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